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Don’t Let Pre-Approval Inspections and the Drug Approval Process Stall Your Application Post

On May 27th, 2016, AstraZeneca announced they received a Complete Response Letter (CRL) from the FDA for their sodium zirconium cyclosilicate (ZS-9) New Drug Application (NDA) (reference link). This... Read More

MannKind Breathes Easier—Inhaled Insulin Finally Approved Post

MannKind’s Afrezza Receives FDA Approval In June of this year, MannKind Corporation announced that they received FDA approval for Afrezza®, their rapid-acting inhaled insulin product. MannKind is currently... Read More

First Generic FDA Review Time to Drop Post

Maybe the title should have a question mark after it – will the review time for a first generic drop? FDA plans to do so – it announced the Generic Initiative for Value and Efficiency (GIVE). Basically, the... Read More

Final Rule—Drug Shortage Regulation: Incentive for Development of “Unapproved” Drugs? Post

Drug shortages can have serious and immediate effects on providing needed therapies to patients, and preventing shortages is a current priority for FDA. FDA has taken a variety of actions to eliminate,... Read More

Start Your New Year Right Post

Do not start the New Year off with CMC issues. Take the time to follow-up on your subcontractors before the FDA finds problems and delays submission approval. Pharmaxis Ltd. just found out the hard way that... Read More

More DESI-Products Cited. Exceptions are Noted for Unique Products. Post

FDA inspections and citations sometimes take a few weeks to appear on the FDA website. So, “news” is a erlative term here. Nonetheless, activity related to DESI drugs has a keen interest to us because they... Read More

Brexit and EMA: The Changes Have Begun Post

After months of speculation, the first round of changes for pharmaceutical manufacturers arising from the planned withdrawal of the United Kingdom of Great Britain and Northern Ireland (UK) from the European... Read More

Manufacturing Problems for Intravenous Emulsions Post

Many of the drug products manufactured by Hospira, including intravenous nutritional emulsions and propofol have been on the market for years. Hospira received a warning letter on April 12th citing two of its... Read More

CMC Issues Again Post

Several previous blogs have discussed the importance of maintaining quality oversight of a contract facility to the drug development timeline. Below is an example of a generic manufacturer with problems... Read More

Do Not Neglect Your Third-Party Drug Substance Manufacturer Post

Another example of the importance CMC was reported in January. Warner Chilcott plc received a complete response letter from the FDA. The “low dose” oral contraceptive NDA was the file in question. The FDA... Read More

Could This NDA Delay Have Been Avoided? Post

Once a new drug application (NDA) has been accepted by the agency for filing, the PDUFA review clock starts. We all know the importance of the shortest time to market. Recently MannKind Corporation issued a... Read More

It’s Budget Time at the FDA! Post

In a time where there are going to be government spending caps and cuts, the Administration is proposing a 23% increase in FDA’s 2011 budget (see pages 19-21). Some of this additional money is proposed to come... Read More

CMC Page

The Camargo team’s early involvement in the product development process saves you substantial time and money. We provide invaluable strategic insights and CMC development services. Read More

FDA Bans 30+ Ranbaxy Generic Drugs—Except 1 Sole Source Post

Today’s (9/17/08) news headlines include reporting on FDA’s ban on the import of more than 30 generic drugs made by Ranbaxy at two manufacturing sites in India. The ban is based on FDA’s adverse inspection... Read More

Foreign Inspections by FDA Post

The US General Accounting Office (GAO) criticised what it concluded is a lack of FDA inspection of foreign API and finished dosage form manufacturers. This has received a lot of coverage in the lay and... Read More

Comparability Protocols Post

What do you need to do when you need to change suppliers or manufacturing sites? Among the many choices is a formal FDA Comparability Protocol. Our VP CMC, Lynn Gold explains. Advance planning can improve the... Read More

Approvals of ANDAs Slows Post

I attended the 2011 Generic Pharmaceutical Association (GPhA) meeting last week. There was lots of useful information from several speakers. One area in particular stood out to me — the approvals of ANDAs are... Read More

The Shutdown from Camargo’s Perspective Post

Now that the FDA has received at least a temporary reprieve from the longest government shutdown in history, we thought we would share some background and a timeline, along with our experience during the... Read More

What is a ‘483? Post

You may read in the news or a company press release that a manufacturing site has received a ‘483. This is usually considered bad news. Indeed, failure to remedy observations in a ‘483 can lead to withheld... Read More

MAPPing Out the Timing of a Complete Response Submission Post

A type of FDA document which sometimes slides past under the radar is MAPP, that is, Manual of Policies and Procedures. These are actually internal FDA documents which are generally analogous to the SOPs FDA... Read More


Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


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list of FDA approvals made under 505(b)(2). As widely reported (WSJ article here) FDA reported that approvals were down in 2010. Frankly,... Read More

CMC Issues Again Post

Several previous blogs have discussed the importance of maintaining quality oversight of a contract facility to the drug development timeline. Below is an example of a generic manufacturer with problems... Read More

505(b)(2)—Part 2: The Assessment: Competitive Product(s) Review Post

We investigate major factors that influence the potential clinical evidence required and the likelihood of a product’s acceptance in the market. Having established a working draft of our labeled indication(s),... Read More

505(b)(2)—Part 2: The Assessment: Safety Review Post

Of course my product is safe! – the RLD was shown to be safe. Perhaps so. The FDA approves products based on a risk/benefit; is the risk of taking the drug outweighed by the benefit? Would FDA approve the RLD... Read More

505(b)(2)—Part 2: The Assessment: Clinical Pharmacology Post

Clinical Pharmacology An overview of the proposed product’s absorption, distribution, metabolism, and excretion (ADME) is detailed in this section obtained from various resources. An important source of... Read More

New Safety Reporting Requirements for Unapproved OTC Products Post

We’ve been observing the FDA crackdown on unapproved DESI and OTC drugs. The reason that Congress and FDA have made these moves is a concern for safety. Industry counters that these drugs have been used safely... Read More

The Importance of the Target Product Profile in 505(b)(2) Development Post

The Importance of the Target Product Profile in 505(b)(2) Development Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken Phelps, President, discuss an... Read More

505(b)(2)—Part 2: The Assessment: Pharmacokinetic Review Post

A comprehensive search of the literature is performed to obtain published pharmacokinetic (PK) data for the proposed product (dependent on selected regulatory pathway). This review compares the PK profiles for... Read More

Foreign Inspections by FDA Post

The US General Accounting Office (GAO) criticised what it concluded is a lack of FDA inspection of foreign API and finished dosage form manufacturers. This has received a lot of coverage in the lay and... Read More

Clinical & PK Page

Camargo meets all applicable U.S. Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulatory requirements, to execute regulatory-compliant clinical trials while reducing overall study costs. Read More

Endpoint for GI Toxicity Clarified Post

NSAIDs are known to induce gastrointestinal (GI) tract toxicity, notably upper GI tract. Drugs that suppress gastric acid secretion such as histamine type 2 receptor antagonists, proton pump inhibitors (PPIs),... Read More

Injectables: 505j or 505(b)(2)? Post

Generic injectable drug products are treated differently than other routes of administration when it comes to permitted differences from the RLD. For most dosage forms, the sponsor is allowed to change... Read More

505(b)(2) Approval Standards—Referenced Studies Post

Awareness of current FDA and its Division standards is important when preparing a new submission. A basic premise for a 505(b)(2) submission to the Agency is that the application contains full reports of... Read More

DESI to 505(b)(2) Raises Drug Costs Post

FDA is trying to remove unapproved new drugs from the market. This past year the FDA approved URL’s colchicine. Previously, FDA announced it was taking action against unapproved colchicine on the market. We... Read More

Sertraline + CBT—a New 505(b)(2) Combo Post

Several news sources report today (10/31/2008) that a new study shows that sertraline in combination with CBT eases anxiety in children. A number of 505(b)(2) development projects arise from observing these... Read More

Recent Developments for Abuse-Deterrent Opioids: FDA and Payers Influence Societal and Market Impact Post

** The requirements for abuse-deterrent opioids are in flux as the FDA grapples with what they can do to address the ongoing opioid epidemic. As part of their efforts in promoting the development of... Read More

Drug Development Planned Like the Titanic Post

How many drug development companies leave it up to the CRO or CMO to design or execute their studies or formulation/manufacturing without oversight? Like those who boarded the Titantic 100 years ago, they seem... Read More

K-V’s Makena Part 4: Statistical versus Clinical Significance Post

In previous postings (Intro, Part 1, Part 2, Part 3), I have provided background on KV’s Makena (17a-hydroxyprogesterone caproate injection aka 17P). The development and regulatory history contains many... Read More

Writing and Submitting Electronic 505(b)(2) INDs Post

Any use of a drug product not previously authorized for marketing in the United States first requires submission of an Investigational New Drug Application (IND) to the FDA. To date, the FDA accepts IND... Read More

MAP Pharmaceutials 505(b)(2) Dihydroergotamine Orally Inhaled Product Meets Phase 3 Goals Post

MAP Pharmaceuticals recently reported good Phase 3 data on its new product in development, Levadex – dihydroergotamine (DHE) orally inhaled. DHE is an old drug that has been used for a long time as an... Read More

Generic Lovenox: 505j or 505(b)(2) Post

Today, Marwood Group Advisory Services broadcast an e-mail giving its thoughts on the approval of Momenta Pharmaceutical’s generic of Lovenox®. This is a very nice write up of the regulatory history, including... Read More

FDA Takes Action Against Compounding Pharmacies’ Estriol-Containing Hormone Products Post

On January 7, 2008, the FDA issued warning letters to several compounding pharmacies (example) advising them stop compounding hormone products contain estriol, an unapproved new drug. This activity has been... Read More

505(b)(2) Literature Searches—Too Much or Too Little? Post

A 505(b)(2) submission relies on information in the public domain to fulfill some of the information required in an NDA for approval. This information comes from more than the reference drug’s NDA review... Read More

Preemption: New Hampshire 1, Sanity 0 Post

On September 30, U.S. District Court (New Hampshire) judge Joseph Laplante decided that Mutual Pharmaceutical was obligated by New Hampshire law to include warnings on its ANDA products not included on the... Read More

Don’t Conduct Unneeded Tox Studies Post

In April I presented a webinar under the auspices of the DIA concerning preclinical bridging. During this webinar, we discussed the need to fill the toxicology gaps that may have been created during the time... Read More

505(b)(2)—Part 2: The Assessment: Clinical Marketing Assessment Post

Competitive Products Review/Clinical Marketing Assessment This section includes an assessment of the existence of a medical need and the ability of the proposed drug to compete with existing and pipeline... Read More

Can and Should ANDA Labeling Differ from the RLD? Post

In the past two months, two appellate courts, the Fifth Circuit and the Eighth Circuit have handed down decisions which essentially state that generic pharmaceutical companies can be sued in state courts for... Read More

Indevus’ Stock Drops 70% on FDA’s Request for More Safety Data Post

On June 4, Indevus Pharmaceuticals reported that the FDA is likely to request additional safety data before approving NEBIDO®, its depot testosterone product for the treatment of male hypogonadism. The news... Read More

505(b)(2) Development Risks Post

We know that 505(b)(2) drug development is chosen because it is lower cost, lower risk and faster than traditional new drug development and offers the potential of greater ROI than generics. But, it is not... Read More

Abuse-Deterrent Opioids—The Insider’s Guide to Innovation and Exclusivity in a Changing Regulatory Landscape Post

As discussed in a previous blog post (here), the 505(b)(2) development pathway provides a flexible path for developers of new abuse-deterrent formulations. The FDA has shown significant motivation and... Read More

One vs. Two Batches for Single-Dose and Multiple-Dose Studies Post

Today’s posting stems from a client question. The client’s product candidate is an oral product that requires both single- and multiple dose pharmacokinetic studies. Question: Do companies ever use one pivotal... Read More

PDUFA 2007—New Submisson Fees for 505(b)(2) Applications Post

Congress just passed the Food and Drug Administration Amendments Act of 2007. Most of us in 505(b)(2) drug development will think of it as the PDUFA 2007 (Prescription Drug User Fee Amendments of 2007). This... Read More

The Winding Path to De-Risking Formulation Changes Post

Originally posted by AAPS Blog 10/7/15 If you are a researcher involved in drug development, you are familiar with the inevitability of change and the need to manage and understand it throughout the... Read More

Europe’s Value Added Medicines Initiative Post

The European Union (E.U.) and the United States (U.S.) both have regulations that allow existing drugs to be improved. The E.U. pathway is limited to improvements of drugs that were approved in the E.U. and... Read More

Manufacturing Problems for Intravenous Emulsions Post

Many of the drug products manufactured by Hospira, including intravenous nutritional emulsions and propofol have been on the market for years. Hospira received a warning letter on April 12th citing two of its... Read More

A Single Phase 3 Trial Needed for 505(b)(2) Approval of a Combination Drug Post

Alchemia Ltd., an Australian pharmaceutical company, announced that it had gained agreement with FDA that a single Phase 3 trial would suffice for approval of its chemotherapeutic drug HA-irinotecan (a new drug... Read More

Suit to Challenge Use of REMS to Block Generics and 505(b)(2) Post

Innovators have used REMS to block generic and 505(b)(2) developers from gaining access to the reference listed drugs (RLD), effectively blocking their development. The 2012 Congress failed to pass legislation... Read More

Fixed-Dose Combination Products—Navigating the Combination Rule Post

Fixed-dose combination products (FDCs), or drugs containing multiple active ingredients, offer benefits to pharmaceutical companies and patients. For Pharma, creative matching of multiple APIs can open new... Read More

Fenofibrate in the News (Again) Post

I recently used the saga of Abbott’s TriCor (fenofibrate) product life extension tactics for an FDA citation to support the use of multiple RLD’s in a 505(b)(2) application. I also think the story is... Read More

Whew! Supreme Court Rules Generic Labels Must Track RLD Post

A lot of generic companies are breathing easier today. As we discussed in this blog before, two district courts ruled that generic companies must comply with state laws and add warnings to the label even if it... Read More

The EU Regulatory Environment: National vs. Central Scientific Advice in the European Union Post

The EU Regulatory Environment Camargo is known for its expertise in the 505(b)(2) pathway. But, in a global pharmaceutical business, many clients are looking to develop drugs for both the US and EU markets.... Read More

FDA Advisory Committee to Review Acura’s Oxycodone Plus Niacin; Risk/Benefit in Question Post

An FDA advisory meeting is scheduled tomorrow (4/22/2010) to review Acura Pharmaceuticals proposed Acurox® (oxycodone + niacin) immediate release tablets. Acura had submitted and NDA in December 2008 and... Read More

FDA Stops DESI Unapproved Rx Narcotics Post

Yesterday, 3/31/09, FDA sent warning letters to nine pharmaceutical companies to stop manufacturing 14 unapproved narcotic drugs. These drugs are unapproved because they were made without NDA or ANDA approvals,... Read More

No 5-Year Exclusivity for Combinations Drugs with an NCE Post

One anomaly to the exclusivity rules is that a combination drug product containing a new chemical entity (NCE) and one or more previously approved drugs does not receive the 5-year exclusivity that a... Read More

505(b)(2) Prodrug Fails Phase III Study Post

Development of drugs for new indications entails more risk of failure than simply changing formulations. Just ask XenoPort, which announced May 19th that its prodrug of R-baclofen, arbaclofen placarbil, failed... Read More

It’s Budget Time at the FDA! Post

In a time where there are going to be government spending caps and cuts, the Administration is proposing a 23% increase in FDA’s 2011 budget (see pages 19-21). Some of this additional money is proposed to come... Read More

NanoNews—Beads Deliver Drug to Site of Action Post

In another fine example of a formulation change, Biocompatibles International reported that its very small beads were used to sequester Doxorubicin (adriamycin). The resulting beads were delivered via a... Read More

Fospropofol Turned Down or Approved by FDA Advisory Committee? Post

MGI Pharma’s Aquavan(R) (fospropofol) is a phosphate prodrug of the anesthetic propofol. Propofol must be administered by an anesthesiologist because of its rapid onset. The phosphate prodrug’s time to onset... Read More

Hospira Expands Into 505(b)(2) Development Post

Hospira, best known as a generic injectable pharmaceutical company, is going to start developing a transdermal product. Yesterday (7/2/2008), Altea Therapeutics announced a partnership with Hospira for the... Read More

2017 505(b)(2) NDA Approvals Increase Dramatically and Review Times Decrease Post

40% Increase in 2017 505(b)(2) Approvals over 2016 The number of 2017 NDA approvals that used the 505(b)(2) regulatory pathway rose dramatically from 45 approvals in each of the last two years to an all-time... Read More

K-V Pharma Bankrupt—Claims FDA Doesn’t Back Makena Post

K-V Pharmaceuticals filed for Chapter 11 bankruptcy. After years of GMP issues narrowed the product offering to just one product, Makena (17-hydoxyprogesterone caproate), poor sales of the product couldn’t... Read More

User Fee Waivers: What is an Affiliate? New Guidance Issued Post

Under the current PDUFA regulations, a small business can request a waiver of the normal review fees for an NDA if it is the first NDA submitted by the small business. The definition of a small business is... Read More

Exalgo Approved Post

Exalgo, hydromorphone extended release tablet was approved March 1, 2010. I waited a couple of days to see if it was approved under 505(b)(1) or 505(b)(2). At this writing, we don’t know. We have previously... Read More

Revised Safety Reporting for BE/BA Studies Effective March 28, 2011 Post

On September 29, 2010 FDA published a Final Rule revising the requirements for safety reporting for INDs and other BE/BA studies. At the same time FDA issued an accompanying draft guidance to assist in... Read More

505(b)(2)—Part 2: The Assessment: Preclinical Review/Preclinical Plan Post

Rats, mice, dogs, pigs – ANDA folks don’t have to deal with testing generic products in animals. As long as the excipients are previously approved, generic drugs don’t have to conduct any preclinical studies.... Read More

Codeine Sulfate: FDA Continues Drive to Remove Unapproved Products, With a Twist Post

Yesterday, October 13, FDA sent Warning Letters to four manufacturers of Codeine Sulfate tablets, 30 and 60 mg: Lehigh Valley Technologies, Inc., Cerovene Inc., Dava International, Inc., and Glenmark Generics,... Read More

Make the Most of Your Interactions With the FDA: FDA Meeting Requests Post

Any meeting with the FDA is critically important to Sponsors. We all know that a tremendous amount of time and effort goes into planning for these meetings. But even before this step the decision to ask for a... Read More

Top Generic CEO’s Confirm Importance of 505(b)(2) in Their Company’s Financial Future Post

Development stage companies are seeing more opportunities to license their products to generic companies. Recently, generic company CEOs reinforced the importance of 505(b)(2)-developed products to their... Read More

First Generic FDA Review Time to Drop Post

Maybe the title should have a question mark after it – will the review time for a first generic drop? FDA plans to do so – it announced the Generic Initiative for Value and Efficiency (GIVE). Basically, the... Read More

FDA Refuse to File: Merck Zetia & Pfizer Lipitor Post

Merck disclosed that FDA refused to file its 505(b)(2) NDA for the combination of Pfizer’s Lipitor (atorvastatin) with Zetia (ezetimibe). According to Merck’s disclosure, the FDA reason for he refusal is: ... Read More

Creating a Safer NSAID Post

Many companies are attempting to reduce the GI bleeding, ulcers and perforations caused by administration of NSAIDS (e.g., ibuprofen, naproxen, aspirin). Since Vioxx was removed from the market (and it was a... Read More

EXAL-still-GO-ing Post

At first, Monday’s (11/16/09) news from CombinatoRx said that the FDA had told the company “that the NDA in its current form would not be sufficient to form the basis for approval of Exalgoâ„¢ under Section... Read More

Qutenza: Approval of a “DESI-inspired” Drug Post

This week, NeurogesX, Inc. announced the FDA 505(b)(2) approval of Qutenza(TM), its 8% capsaicin patch, for management of post-herpetic neuralgia (PHN) – the nerve pain that can follow an attack of shingles.... Read More

Watson’s 505(b)(2) Overactive Bladder Gel Approved by FDA Post

On 1/27/2009 Watson Pharmaceuticals announced that the FDA had approved its GELNIQUE(tm) (oxybutynin chloride) Gel 10% for the treatment of overactive bladder. The gel product supplements a transdermal patch... Read More

Camargo Appoints K. Gary Barnette as Vice President of Drug Development Media

Date: May 22nd, 2012

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Mitosol—An Orphan & 505(b)(2) without clinical studies Post

Mobius Therapeutics announced that it has received orphan drug status for Mitosol to prevent the recurrence of pterygium after surgical excision. The active ingredient, mitomycin has been used without FDA... Read More

Camargo’s Ready 4 Action Assessment Helps Generic Drug Companies Overcome the Patent Cliff Media

Date: February 5th, 2014

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Israeli Drug Development Companies are Poised for 505(b)(2) Development Process, Camargo Expert Says Media

Date: December 17th, 2013

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Nonclinical Page

Ready to guide you through nonclinical in vitro and in vivo requirements, Camargo provides our own proven methodologies, strategic support and nonclinical testing services in a full range of areas. Read More

505(b)(2) Success Requires More Than Just Science Post

At the JP Morgan Conference/Biotech Showcase this year, we encountered a record number of companies engaged in 505(b)(2) development. We also had meetings with investors and buyers with their checkbooks open to... Read More

505(b)(2) Head Lice Treatment Approved Post

FDA announced on April 9 that it had approved Sciele Pharma’s benzyl alcohol lotion, 5% for the first-line treatment of head lice. Sciele was recently acquired by Shionogi Company. Sciele licensed this product... Read More

2012 505(b)(2) Approvals—Record Year Post

Nice going! 2012 saw a record number of 505(b)(2) drugs approved – 47. As is usual at this time of the year, I have prepared a listing of all of the approvals. This year, I have made the listing more useful –... Read More

The Camargo Way Page

Camargo's experience with pharmaceutical research and strategies enables us to identify the optimal path to better outcomes. Read More

Approvals of ANDAs Slows Post

I attended the 2011 Generic Pharmaceutical Association (GPhA) meeting last week. There was lots of useful information from several speakers. One area in particular stood out to me — the approvals of ANDAs are... Read More

PDUFA Fee Waiver: Plan Ahead Post

For an original NDA, whether it is a 505(b)(1) or 505(b)(2), there is a PDUFA fee to be paid at the time of the submission of the application or the FDA will refuse to file it. For a small business ( a company... Read More

Current versus RLD Approval Requirements Post

A 505(b)(2) NDA has the same approval requirements as a 505(b)(1) NDA, the only difference is where the pivotal data comes from . 505(b)(2) is not a shortcut in the sense that you can get by with less... Read More

Transcept and Novacea to Merge Post

Transcept Pharmaceuticals (formerly TransOral) announced today (9/2/2008) that it is merging with Novacea. Transcept is a privately held company while Novacea is NASDQ-listed, so the merged company will be a... Read More

New FDA Guidance Illustrates Breadth of 505(b)(2) Development Programs Post

It is clear the FDA recognizes the range of development possibilities made possible by the 505(b)(2) pathway, as illustrated by the recently released draft guidance for the development of depot buprenorphine... Read More

CMC Page

The Camargo team’s early involvement in the product development process saves you substantial time and money. We provide invaluable strategic insights and CMC development services. Read More

V ClinBio Partners with Camargo for Strategic 505(b)(2) Development of Transformative Prodrug Technology Platform Media

Publication: Camargo Pharmaceutical Services, via PR Newswire

Date: March 6th, 2018

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What to Develop? Post

Not all clients come to us with product ideas. Indeed, they want us to help identify a short list of suitable candidates. Example companies might include technology platform companies. How do we go about... Read More

Solutions Page

Camargo can guide and support you in all elements of the drug development lifecycle, from the earliest stages of strategic planning and assessment through FDA approval and commercialization. Read More

News on the Biosimilar Front Post

Tuesday, February 2nd, Teva Pharmaceuticals announced that the FDA will review its new biologic license application (BLA) to sell a biotechnology medicine, Neutroval, to boost white blood cells, which is... Read More

Racemate > Isomer Approval Under 505(b)(2) Post

The 505(b)(2) process is used to obtain approval of an isomer of an already approved racemate. An example is cetirizine. The original product approved (Zyrtec) is a racemate. In May 2007, UCB, Inc. obtained... Read More

Post-Marketing Nonclinical Case Study Page

To learn how Camargo’s rapid planning and coordination kept a sponsor’s post-marketing requirements on track, read this nonclinical case study. Read More

ViroPharma Denied Request for 3-year Exclusivity Post

ViroPharma has pulled out all stops to prevent generic copies of its off-patent Vancocin® capsule (vancomycin hydrochloride) including the use of the Citizen Petition process. Recently, FDA denied most of the... Read More

Spending on DTC Advertisements Post

At GPhA last week, one of the CEO’s on an industry panel said that big pharma spent more on DTC (direct-to-consumer) advertising than on R&D. Clearly, generic companies don’t like this promotional activity,... Read More

PhRMA Adds New Bio Companies Post

The trend in Big Pharma continues to shift from small molecules to biologics. PhRMA announced that it added seven (7) new members to its roster at the end of the year. The new PhRMA members are Cubist... Read More

A Primer on the 505(b)(2) Pathway for Combination Drug/Device Products Media

Publication: Pharmaceutical Online

Date: February 16th, 2016

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India’s Drugmakers Step Up US Involvement Media

Publication: The Wall Street Journal, article by Suryatapa Bhattacharya

Date: February 24th, 2016

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FDA Halts Marketing of Topical Ibuprofen Products Post

Noting that topical ibuprofen drugs are not included in any OTC monograph or the subject of any approved NDA, the FDA has issued warning letters (click hyperlink to FDA warning letter) to eight... Read More

FDA Goes Against Advisory Committee and Approves Low Dose Paroxentine for Hot Flashes Post

On 6/30/2013, FDA approved Noven Pharmaceuticals Brisdelle (paroxetine) for the treatment of vasomotor symptoms (hot flashes). This 505(b)(2) approval is notable since it is the first non-hormonal product... Read More

Expertise Page

Camargo began helping companies navigate the 505(b)(2) regulatory pathway with FDA approvals, and is now a full-service partner of choice for pharmaceutical product development companies around the globe. Read More

Why More Drugs than Ever Are Approved Through 505(b)(2) Media

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505(b)(2—Part 3: Pre-IND Submission & Meeting Post

Before filing an IND, it is desirable (we counsel imperative) to have a pre-IND meeting with the FDA. The goal is to get FDA’s concurrence with the proposed development plan and regulatory submission pathway.... Read More

Identifying Products for Drug Development Programs Media

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505(b)(2) Combo Plavix/Prilosec Post

Cogentus Pharmaceuticals is working on a combination tablet that combines clopidogrel, the active ingredient in Plavix, with omeprazole, the API in Prilosec. Cogentus’s business strategy is to: “…... Read More

More DESI-Products Cited. Exceptions are Noted for Unique Products. Post

FDA inspections and citations sometimes take a few weeks to appear on the FDA website. So, “news” is a erlative term here. Nonetheless, activity related to DESI drugs has a keen interest to us because they... Read More

Case Studies Page

Camargo develops highly customized programs, with extensive experience in all stages, including clinical research studies, FDA registration and approval, and commercialization. Read More

NIH Head Urges Repositioning/Repurposing Post

In a speech at yesterday’s 2012 TEDMED conference, the head of the NIH, Dr. Francis Collins, said that there is a big gap between basic research and drugs for patients. To bridge this gap he suggested ‘some of... Read More

FDA Moving Against Unapproved Hydrocodone Products Post

FDA is announcing that it intends to remove all unapproved products containing hydrocodone from the market. The FDA intends to swiftly move against products labeled for use in children under 6 years of age and... Read More

Trade Secrets Post

According to some observers, the US Patent system is undermining innovation. In KSR International versus Teleflex Inc., the US Supreme Court ruled that patents must be “more than the predictable use of prior... Read More

Ruth Stevens Leadership Team

Dr. Ruth Stevens has more than 20 years of experience in the development of new drugs and therapeutic agents. She has led more than 100 FDA regulatory meetings in her career and continues to lead numerous... Read More

Dexlansoprazole Approved for the Treatment of GERD Post

This past Friday, 1/30/2009, the FDA approved Takeda Pharmaceuticals North America Kapidex (dexlansoprazole) for the treatment of gastroesophageal reflux disease (GERD). Kapidex is an enantiomer of lansoprazole... Read More

Camargo Blog Page

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Raptor Announces Orphan Designation for Cysteamine Bitartate Post

Raptor Pharmaceuticals announced that the FDA has granted orphan drug designation for cysteamine bitartrate for the treatment of Huntington’s disease. Cysteamine is currently approved by the FDA and European... Read More

REMS for 505(b)(2) Products? Post

Camargo has been involved in the development of several opioids and is often contacted by new sponsors to develop alternate formulations. One question often brought up is: does a 505(b)(2) approved opioid... Read More

Medicaid Paid for Unapproved DESI Drugs Post

A minor ripple in the media, the Associated Press reviewed Medicaid records and found that since 2004, Medicaid has paid at least $200 million for unapproved drugs (perhaps $50MM per year). “Unapproved” sounds... Read More

Patent Cliff Causes Pfizer Cuts Post

Yesterday (08Jun11) The Wall Street Journal reported (subscription may be required) that Pfizer will cut an additional $1 Billion – mostly in administrative costs. These cuts come after cuts to sales and... Read More

Importing Pre-Launch Products with a Bit of PLAIR Post

With the tsunami of activities connected with the initial implementation of all the GDUFA requirements, another change made by FDA went largely under the radar. FDA released the draft guidance, “Pre-Launch... Read More

Privacy Policy Page

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Raptor’s Procysbi Costs More Than A Generic (!) Post

Again we have the media troubled by new, improved drugs that cost more than the generic they are based on rather than trumpeting the improvements. Raptor Pharmaceutical received approval of its Procysbi... Read More

505(b)(2) IV Acetaminophen Post

Cadence Pharmaceuticals announced yesterday 5/14/2009 that it had submitted an NDA for Acetavance(TM) – intravenous acetaminophen. It is instructive to look at the clinical development plan for this 505(b)(2)... Read More

Generic Biologics Post

This past week I attended the 2009 Generic Pharmaceutical Association annual meeting. Much time was devoted to the issue of generic versions of biologics. Adding to the debate was the what to call these drugs.... Read More

Could This NDA Delay Have Been Avoided? Post

Once a new drug application (NDA) has been accepted by the agency for filing, the PDUFA review clock starts. We all know the importance of the shortest time to market. Recently MannKind Corporation issued a... Read More

Generic Approvals Taking Longer Post

I attended the Annual GPhA meeting this past week. This event is attended by the CEO’s and other top brass of most of the major generic pharmaceutical companies. This year was highlighted by a presentation from... Read More

505(b)(2)—Giving Thanks Post

No turkey, no Black Friday specials, just a thank you note. Little did we know that in 1984 Congress would provide for a regulatory pathway that would provide such a cornucopia of beneficial products that we... Read More

Linking Preclinical (Safety), Clinical (Efficacy) and CMC (Quality) Development Activities Post

Camargo is often called on to write and/or assemble NDAs. When we get to prepare an NDA from the beginning, all of the information builds and the resulting ‘story’ is easy for the FDA to understand. Often we... Read More

Use CMO’s Labs or Outside Labs Post

Why does Camargo recommend not to use a CMO’s testing lab for development? CMO labs are tailored for commercial production, characterized by many SOP’s and schedules. During early drug development we need... Read More

Aequus and Camargo Complete Pre-Investigational New Drug Submission with FDA for Transdermal Anti-Nausea Program Media

Publication: Aequus Pharmaceuticals, via Globe Newswire

Date: April 17th, 2018

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Camargo Pharmaceutical Services Grows, Adds Three Drug Development Experts Media

Publication: Camargo Pharmaceutical Services, via Newswire

Date: August 10th, 2016

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A Green Card Is No Longer a “Green Light”—Changes to FDA Security Policy Post

Changes to FDA Security Policy If you have been to a meeting at the FDA recently, you may have experienced the roller coaster that is their parking/visitor drop-off policy. There have been so many changes that... Read More

Daniel S. Duffy Leadership Team

In 2018, Dan Duffy joined Camargo Pharmaceutical Services as chief executive officer. With a people-centered leadership style, Duffy’s focus is on establishing Camargo as the preferred global partner for drug... Read More

RLD—Born in the USA Post

You have a global perspective and drug development program. You want to conduct studies in the US and an international location. You’re going to use an RLD from Big Pharma – you know, the global giants. The RLD... Read More

Brexit and EMA: The Changes Have Begun Post

After months of speculation, the first round of changes for pharmaceutical manufacturers arising from the planned withdrawal of the United Kingdom of Great Britain and Northern Ireland (UK) from the European... Read More

Camargo Meets Growing Client Needs with Appointment of Industry Leader Steven Castillo as Vice President of Drug Development Media

Date: October 29th, 2014

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How to Achieve Successful 505(b)(2) Drug Development: A Well-Executed Pre-IND Meeting Webinar

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505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success Webinar

The 505(b)(2) regulatory pathway enables a lower cost, lower risk, and faster path to regulatory approval and market. With early strategy, it is possible to set up a program from the beginning to improve the... Read More

Regulatory Page

Camargo offers a full range of FDA regulatory support, including FDA regulatory compliance and guidance expertise. Read More

New PDUFA V Meeting Timelines Post

PDUFA V ushered in new industry and FDA commitments. Among these are changes in meeting timelines. A significant change from PDUFA IV is the timeline for Type A meetings. Under PDUFA IV the meeting package was... Read More

505(b)(2) of Withdrawn Product Post

A source of 505(b)(2) opportunities comes from products that have been discontinued. One of the first things that must be done is to determine why it was discontinued – by law, the product must not have been... Read More

505(b)(2) Seminar Webinar

This seminar benefited executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2) drug development, which enables a lower cost, lower risk, and faster path to regulatory... Read More

Shionogi to Buy Sciele Pharma Post

Shionogi, a Japan-based pharmaceutical company, announced yesterday (9/1/2008) that it would buy Atlanta-based Sciele Pharma for $1.42 billion – 57% premium to the current share price. Shionogi’s analysis of... Read More

Start Your New Year Right Post

Do not start the New Year off with CMC issues. Take the time to follow-up on your subcontractors before the FDA finds problems and delays submission approval. Pharmaxis Ltd. just found out the hard way that... Read More

Regulatory Scientist Career Posting

Location: Multiple states

Type: Full Time

Minimum Experience: Entry Level

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BDSI’s Buccal Fentanyl 505(b)(2) NDA Approved Post

BioDelivery Sciences International received FDA approval of its 505(b)(2) NDA for buccal fentanyl on July 16, 2009. Most notable about this approval is the first REMS (Risk Evaluation and Mitigation... Read More

Melphalan—New 505(b)(2) Orphan Designation Post

Delcath Systems Inc. announced that the FDA has granted an additional orphan designation for melphalan for the treatment of neuroendocrine tumours metastatic to the liver. Delcath uses a proprietary system they... Read More

505(b)(2) Combination Products Post

During the Q&A after my audioconference yesterday a participant asked if a proposed drug product containing 1 new drug and 2 already approved drugs would be a 505(b)(2). Although she didn’t say so, I... Read More

Getting Unapproved Drugs (DESI, etc.) Approved Post

FDA uses the term ‘Unapproved Drugs’ to refer to any drug that is marketed in the U.S. without FDA approval. There are hundreds, maybe thousands of these drugs in the U.S.. We have written about the efforts of... Read More

Deuterization: Is it Enough to Get 5- or 7-Year Exclusivity for a 505(b)(2) Product? Post

As the 505(b)(2) experts, Camargo has received several enquiries about developing deuterated drugs as a means of achieving sustained-release properties for a product. The approval of Austedo (deutetrabenazine;... Read More

Product Selection: Which Product to Develop? Post

Product Selection and the Importance of Early Strategic Design for Success Why do some new drug products gain approval, but launch with lower-than-anticipated drug sales? Why then can some drug products gain... Read More

Why You Need Camargo’s Cutting-Edge Pharmacokinetics Team Involved in Your 505(b)(2) Program: Can We Really Do That? Post

If you think regulatory pharmacokinetics requirements are just a box-checking exercise then you may be throwing away money and time on unnecessary studies. At Camargo, we have always focused on innovative... Read More

Biosimilars—An introduction Post

Related to the current frantic activity regarding health care in the US, there is a smaller struggle concerning biosimilars that in many ways mirrors the larger health care struggle. Drug products made from... Read More

Two Investigational Applications for One Drug Product? IVD Device Requirements Post

A New Draft Guidance Provides In Vitro Diagnostic Device Requirements That May Impact Therapeutic Drug Trials Did you know that an assay used in a clinical trial designed to study an investigational drug may... Read More

A Vitamin Approved as a Drug(!): Forget What You Think You Know to Be True Post

Dogma says that a compound used for a nutrition, such as a vitamin, cannot be a drug. Such dogma prevents the development of many good drugs. The FDA just approved vitamin C – ascorbic acid as a drug. Read on... Read More

Chemistry, Manufacturing, and Controls Requirements: Bridging and 505(b)(2) Post

One of the main causes of Refusal to File / Receive actions by the US FDA is due to inadequate Chemistry, Manufacturing, and Controls (CMC) data. This missing data relates to formulation issues, incomplete... Read More

Dramatically Decrease Drug Development Costs Through Literature-Only 505(b)(2) NDA Submissions Post

Dramatically Decrease Drug Development Costs Through Literature-Only 505(b)(2) NDA Submissions How would you like to get an NDA approved without conducting any clinical studies? Camargo presented a poster on... Read More

505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success, Q&A Part 2 Post

Last week, we posted the first part of Q&A from recent webinar 505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success Camargo President and Co-founder, Ken Phelps, held with Fierce... Read More

GDUFA I and II: Considerations for Complex Generics Innovators Post

The increasing complexity of brand-name drugs has made development of generic alternatives more challenging as well. As complex generic drug products can provide a high-value opportunity for drug development... Read More

ANDA Suitability Petition vs 505(b)(2) Post

I was honored to be invited to speak at the FDA-OCRA 12th Annual Educational Conference in Irvine California on June 10, 2009. I was asked to discuss and compare the 505(b)(2) and ANDA Suitability Petition. I... Read More

Don’t Let Pre-Approval Inspections and the Drug Approval Process Stall Your Application Post

On May 27th, 2016, AstraZeneca announced they received a Complete Response Letter (CRL) from the FDA for their sodium zirconium cyclosilicate (ZS-9) New Drug Application (NDA) (reference link). This... Read More

Exclusivity GAINs Additional Indications: Advantages of QIDP Designation Paired with 505(b)(2) Strategy Post

Additional Indications: Advantages of QIDP Designation The benefits of early strategy for 505(b)(2) drug development programs are numerous, but none as substantial as market exclusivity. Incentives available... Read More

PREA and 505(b)(2) Post

Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required... Read More

New Nonclinical Guidance for 505(b)(2) Products: No Cause for Alarm Post

On October 15, 2015, the United States Food and Drug Administration (FDA) issued a new guidance for industry and review staff with more uniform recommendations for the nonclinical safety evaluation of approved... Read More

Drug or Device?—FDA Provides More Clarity—Or Does It? Post

Drug or Device?—FDA provides more clarity—or does it? Industry has complained for years, and for good reasons, that it is difficult to understand FDA’s determination of whether a combination product would be... Read More

Unforced Errors: FDA Refusal to File or Receive Letters Post

UNFORCED ERRORS: FDA Refusal to File or Receive Letters Few things can be more damaging to a pharmaceutical company than the refusal by the Food and Drug Administration (FDA) to review their New Drug... Read More

Pediatrics—What are the appropriate age ranges? Post

As we have noted in this blog previously, under the Pediatric Research Equity Act (PREA), all new drug applications for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route... Read More

Innovative Thinkers: FDA Wants YOU Post

New FDA Guidance on OTC Products FDA just released a very brief (barely three pages of actual text) guidance promoting innovation in new drug applications (NDAs) involving nonprescription (aka... Read More

Effects on Combination Products: The Biologics Price Competition and Innovation Act of 2009 Post

On March 23, 2010, the U.S. FDA enacted the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as part of the Patient Protection and Affordable Care Act (Public Law 111-148). Under BPCIA,... Read More

Complex Generics Getting Too Complicated for the Generic Approval Pathway? GDUFA II and the Pre-ANDA Program to the Rescue Post

Finally there is hope for Sponsors of complex generics with the new Pre-ANDA program outlined in GDUFA II. More good news: the 505(b)(2) experts have got you covered for the development of complex... Read More

A Review of the Regulatory History of Azelaic Acid and the Changing Requirements at FDA Post

Shifting views on the safety of drug substances at FDA are not uncommon with the advent of new scientific findings or upon better understanding of physiological processes or disease states. With time, these... Read More

Abuse Deterrence Labeling—Generic vs 505(b)(2) Drug Development Post

Abuse Deterrence Labeling – Generic vs 505(b)(2) Drug Development With the ongoing opioid epidemic, drug abuse, diversion, and misuse are significant concerns for the FDA. The current opioid abuse problems... Read More

Key Inflection Point in a Drug’s Time to Market: Choice of Regulatory Pathway Post

Traditional drug development follows a standard process beginning with nonclinical studies and moving into clinical studies, all with the purpose of proving a new drug candidate is safe and effective. When the... Read More

Real-World Evidence: Can It Really Be Used for Drug Approvals? Post

With the signing of the 21st Century Cures Act, the US Congress tasked the FDA with developing a framework to evaluate how the use of data from sources other than traditional clinical trials may be used to... Read More

Camargo Counsel: The Cost of Wrong Post

Here at the Camargo 505(b)(2) blog, we are adding a new voice to mix in with the technical writing. These candid takes will be given by our experts in drug development and sprinkled in with the usual fare.... Read More

Advisory Committee Meeting: Rosiglitazone Post

The media is crazed with interpretations of the FDA and GSK briefing materials for the Advisory Committee meeting this week regarding the safety of Avandia (rosiglitazone). For those readers who’d like to read... Read More

Improvements and Updates to the FDA Inactive Ingredient Database Post

Improvements and Updates to the FDA Inactive Ingredient Database The FDA recently announced it has made corrections, updates, and additions of a backlog of formulations to the Inactive Ingredient Database... Read More

Seamless Clinical Trials: Why Didn’t We Think of That? Post

Seamless clinical trials have become the new buzz word in drug development since FDA Commissioner Scott Gottlieb promoted their use this month. But are they new, and which products are best suited to this style... Read More

505(b)(1) versus 505(b)(2): They Are Not the Same Post

The 505(b)(2) pathway can yield significant benefits in drug development cost and time. But what are the differences in 505(b)(1) versus 505(b)(2)? They are not the same. Drug development pathways in the... Read More

Ophthalmics: 21 CFR 314 94(a)(9)(iv) No Longer Applies Post

Who would have guessed that 21 CFR 314.94(a)(9)(iv) no longer applies to ophthalmics? You wouldn’t generally have expected it to just be cancelled – normally FDA must go through notice and comment, but... Read More

Rx-to-OTC Switch: Expanding to the US Over-the-Counter Market Post

Changing the marketing status of a drug from prescription (Rx) to over-the-counter (OTC), known as an Rx-to-OTC switch, can increase drug utilization by an average of 30% (Stomberg et al. 2013). According to... Read More

What Went Wrong? Important Considerations for Studies Outside the United States Post

We are pleased to announce a new format and series to add to our 505(b)(2) Blog: a video blog / podcast called What Went Wrong? For our first episode, Ken Phelps, CEO, and Dr. Ruth Stevens, CSO, Camargo... Read More

505(b)(2): Repositioning, Repurposing or What? Post

Last week I made a presentation at the Society of Biomolecular Sciences (SBS) 2010 Annual Meeting in Phoenix (due to the Iceland volcano eruption, many participants are still there). The occasion was the... Read More

Clinical Trials with Multiple Endpoints: Pitfalls and Management Post

Randomized controlled Phase 3 (and some Phase 2) studies are clinical trials that are designed to answer specific questions, such as whether the proposed drug is effective in treatment or prevention of a... Read More

Expedited Approval of FDA-Approved Drugs in Australia Post

Expedited Approval of FDA-approved drugs in Australia: New Market Opportunities for Drugs and Devices In the past, after gaining approval for a drug/device in the United States, subsequent approval in... Read More

The Potential Unveiling or Unraveling of Dormant Therapies—15-Year Data Exclusivity for Drugs for Unmet Needs Post

Last week the “Dormant Therapies Act” (DTA), a companion piece to the Modernizing our Drug & Diagnostics Evaluation and Regulatory Network Cures Act (also known as the MODDERN Cures Act of 2013), was... Read More

When is an IND Required? Post

Most of us know that a BA/BE study of a generic can be done without an IND (the exception, called a Bio-IND, is when the drug being studied is cytotoxic or a radioactive labeled drug). In 505(b)(2) drug... Read More

K-V’s Makena: Part 3: Use of Public Information for 505(b)(2) Approvals Post

In previous postings (Intro, Part 1, Part 2), I provided background on KV’s Makena (17a-hydroxyprogesterone caproate injection aka 17P). The development and regulatory history contains many lessons. In this... Read More

Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products Post

We believe that the 505(b)(2) drug development pathway is best used when we can improve the safety and/or efficacy of an existing drug product. We see many opportunities to improve clinical effectiveness, but... Read More

PREA Requirements for Biosimilar and Interchangeable Biological Products Post

In general, under the Pediatric Research Equity Act (PREA), submission of an initial pediatric study plan (iPSP) is required for a drug or biological product that includes a new active ingredient, new... Read More

Extrapolation of Clinical Data for Pediatric Uses: Application for Medical Devices and Drug Products Post

Extrapolation of Clinical Data for Pediatric Uses: Application for Medical Devices and for Drug Products Extrapolation of Clinical Data for Medical Devices1 The Food and Drug Administration released the... Read More

Increase the Value of Your Prodrug Asset Under 505(b)(2): An Alkermes Program Update Post

A prodrug developed via the 505(b)(2) pathway can improve an existing therapeutic while increasing the value of the asset. The therapeutics which excite us most here at Camargo are drugs which deliver effective... Read More

Which Product to Develop? Product Selection and the Importance of Early Strategic Design for Success Webinar

Product Selection and the Importance of Early Strategic Design for Success Why do some new drug products gain approval, but launch with lower-than-anticipated drug sales? Why then can some drug products gain... Read More

Improving NDA Approval Odds for New Dosage Forms of Approved Products Post

Improving NDA Approval Odds for New Dosage Forms of Approved Products There are numerous reasons why a Sponsor may wish to market a new dosage form of an approved product. Aside from the obvious financial... Read More

Enforcement Activities: FDA Removes Unapproved Prescription Ear Drops Post

For years FDA has threatened to remove unapproved products (so-called DESI products) from the marketplace. Recently, the FDA took enforcement action against several unapproved prescription ear drops. What... Read More

Faster Approval of Combination Drug Products via the 505(b)(2) Pathway Post

On April 11 and 12, 2016, Ken Phelps, President and CEO of Camargo Pharmaceutical Services, spoke at the 505(b)(2) Forum and CTrials Conference in Tel Aviv, Israel, on the topic of 505(b)(2) Combination Drug... Read More

Therapeutic Equivalence Ratings Under 505(b)(2) Post

The FDA listing of therapeutic equivalence (TE) ratings can be a murky area for products approved under 505(b)(2) applications. The concept of TE ratings emerged from FDA regulations for generics and revolve... Read More

Pitfalls of Changing the Salt of a Listed Drug Post

Pitfalls of Changing the Salt of a Listed Drug The 505(b)(2) registration pathway for new drug products allows the applicant of the new drug product to reference the literature and the FDA’s findings of... Read More

To List or Not to List—That is the Question Post

A 505(b)(2) may rely on the FDA’s previous findings of safety and efficacy of an approved drug product. It is possible to rely on more than one approved drug product. It is also possible that a 505(b)(2)... Read More

Risk Evaluation and Mitigation Strategies (REMS) Basics Post

The Food and Drug Administration is responsible for ensuring that human drugs are safe and effective, while also advancing public health by helping to speed product innovations. In determining if a drug should... Read More

Fixed-Combination Drug Products: Are Phase 2 and 3 Studies Really Necessary? Post

Many fixed-dose drug-drug combination products arise from an observation that a synergistic effect occurs when two drugs are administered together, or that both drugs are frequently taken together for... Read More

How to Get Orphan Status for 505(b)(2) Drugs Post

2017 was a big year for orphan designations and approvals. Sixteen of the sixty-three (25%) products approved via the 505(b)(2) pathway in 2017 received orphan designation. Importantly, more than half of the... Read More

Getting Liposome Drug Products Approved: They Are Non-Biological Complex Drugs Post

Liposome drug products frequently contain an already-approved drug, and can utilize the 505(b)(2) pathway to approval. Liposomal drug products are a sub-group of Non-biological Complex Drugs (NBCD) and contain... Read More

The Road to Commercial Success—The Target Product Profile Post

The goal of drug product development is commercial success. If this statement wasn’t true, how would patients access the live-saving or life-enhancing drugs we are developing. Yet, all too many companies focus... Read More

The Prodrug Benefit of Utilizing the 505(b)(2) Pathway Post

Designing a new drug from scratch is costly and time-consuming. One attractive option to differentiate from currently marketed products is to chemically modify the characteristics of an existing drug to create... Read More

Are Botanical Drugs, Herbal Medicinal Supplements, and Natural Product Drugs 505(b)(2)s, Too? Post

In recent years, pharmaceutical companies have turned to botanical drugs for alternative medicines to treat diseases with unmet medical needs. The FDA also recognizes the interest in developing botanical... Read More

Complex Generic Drug Products: A Changing Regulatory Landscape Post

Earlier this year, the U.S. Food and Drug Administration (FDA) announced its Drug Competition Action Plan, which aims to bring more competition to the drug market and improve consumer access to drugs. As part... Read More

FDA 2014 NDA Approvals—The Surge of the Niche Products—Good or Bad? Post

The FDA recently provided a summary of new drug approvals in 2014 pointing to an 18-year high. According to its website, the FDA approved 41 novel medicines in 2014, 14 more than in 2013. Nearly 40% of the new... Read More

The Value of a Strategic Assessment: Aligning for Success from the Start Post

The Value of a Strategic Assessment The first step for every wise drug developer beginning a drug development program is to determine the feasibility of a proposed product by asking several high-level... Read More

Scope of Orphan Drug Exclusivity - Post

It has recently been reported that drugmakers have argued against broad orphan exclusivity for Eagle Pharmaceuticals, Inc.’s Bendeka® product. This was in response to the FDA’s invitation to applicants of... Read More

Final Rule—Drug Shortage Regulation: Incentive for Development of “Unapproved” Drugs? Post

Drug shortages can have serious and immediate effects on providing needed therapies to patients, and preventing shortages is a current priority for FDA. FDA has taken a variety of actions to eliminate,... Read More

Orphan Exclusivity for ‘Same Drug’: What Has Changed Since FDARA 2017/ PDUFA VI? Post

Last month the US District Court for the District of Columbia ordered the FDA to grant Eagle Pharmaceuticals, Inc., 7-years of marketing exclusivity for Bendeka® (bendamustine). This was the second loss for the... Read More

DESI Drugs: Potential Targets for Quick Approvals Post

DESI Drugs: potential targets for quick approvals Drugs that are on the market but are not approved by the FDA are more common than you might think. Even some physicians might be unaware that the drug they are... Read More

Referencing a Listed Drug for the 505(b)(2) Pathway Post

Section 505(b)(2) of the Food, Drug, and Cosmetic Act describes a 505(b)(2) new drug application (NDA) as an application where at least some of the information required for approval comes from studies not... Read More

505(b)(2) Application Changes: What You Need to Know Post

505(b)(2) Application Changes: What You Need to Know Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 was enacted in order to address concerns that had potential to... Read More

Looking for Clarification on Reporting Post-Approval Changes to a Drug Substance to the FDA? You are in Luck. Post

This week the FDA released a new draft Guidance for Industry entitled “Post-approval Changes to Drug Substances” as part of the FDA’s commitment to the reauthorization of the Generic Drug User Fee Amendments... Read More

K-V’s Makena® Part 1: 505(b)(1) or 505(b)2)? Post

In a previous posting, I provided background on KV’s Makena (17?-hydroprogesterone caproate injection aka 17P). The development and regulatory history contains many lessons. In this posting I’d like to examine... Read More

Protein Product 505(b)(2)s Face a Looming Application “Dead Zone” Post

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was enacted on March 23, 2010 as part of the Patient Protection and Affordable Care Act (Public Law 111-148). The BPCIA changed the regulation... Read More

Opportunities in Orphan Drug Development for Investors, Pharma and CROs Post

Orphan drugs, defined in the Orphan Drug Act as drugs developed to treat rare diseases that affect fewer than 200,000 people in the U.S., have begun to make their mark for patients and drug companies. As the... Read More

On the Rise: 2016 505(b)(2) NDA Approvals Post

On the Rise: 2016 505(b)(2) NDA Approvals The total number of novel drug approvals in 2016 decreased by approximately half from last year (22 in 2016, from 45 in 2015) and is below the 10-year average of 29... Read More

Leveraging Postmarketing Safety Data in 505(b)(2) Drug Development Programs Post

A significant part of the FDA’s charge is ensuring the safety of drugs available to the public. While a substantial part of the FDA’s efforts in guaranteeing public safety go into the safety assessment process... Read More

Alkermes Prodrug for Treatment of Multiple Sclerosis: NCE? Post

The Food and Drug Administration (FDA) began requiring drug efficacy, in addition to safety, for approval in 1962 based on the Kefauver-Harris Amendment. Despite this requirement, many drugs that have been... Read More

Product Ideation: Identifying Your Optimal Drug Development Candidate Post

It’s a familiar story: Pharmaceutical Company X spends years developing Product Y only to discover at a crucial point in the process that Product Y will not succeed. The result is often millions of dollars and... Read More

Statistical Bootstrapping Method to Take the Uncertainty out of Drug Development Post

Statistical Bootstrapping Method Using a Bias-Corrected Acceleration Approach Well-reasoned and properly conducted statistical analyses can be essential to successful drug development, particularly in the... Read More

Drug Development Question? Here’s How to Communicate With the FDA! Post

Earlier this month FDA (CDER and CBER) issued a new draft guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development. Based on Camargo’s frequent communications with the... Read More

De-Risking Drug Development Post

High-level Reasoning and Technical Methodology for Evaluating a Program’s Risk From a distance, 505(b)(2) product development can seem very straightforward for products that have been on the market or in... Read More

2015 505(b)(2) NDA Approvals Post

2015 was a big year for FDA, with 45 novel new therapies approved — much higher than 28, the average number approved in the past decade. Of the 45 approved in 2015, how many were approved through the 505(b)(2)... Read More

505(b)(2) CMC Basics: Aligning Chemistry, Manufacturing, and Controls with Clinical Trials Post

Aligning Chemistry, Manufacturing, and Controls with Clinical Trials Nine times out of ten, a sponsor approaches their 505(b)(2) drug development process without a clear plan for Chemistry, Manufacturing, and... Read More

Drug Repositioning: Bringing New Life to Shelved Assets and Existing Drugs Post

Drug repositioning, also known as drug reprofiling or repurposing, has become an increasingly important part of the drug development process. This book examines the business, technical, scientific, and... Read More

A 505(b)(2) Qualified Infectious Disease Product QIDP Designation—8 Years of Exclusivity Post

A 505(b)(2) with 8 years of exclusivity. That is the prize that Calla Therapeutics will receive upon approval of its innovative vaginal cream drug candidate for the treatment of recurrent vulvovaginitis (RVVC).... Read More

Use of Clinical Data in a 505(b)(2) New Drug Application to Delay Nonclinical Testing Post

Use of Clinical Data in a 505(b)(2) New Drug Application to Delay Nonclinical Testing As part of the 505(b)(2) drug development and registration process, the applicant of the new drug product can reference the... Read More

Back to Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies Post

As the 505(b)(2) expert, Camargo is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Given the growing popularity of the... Read More

505(b)(2) Nonclinical Development: Examples and Advantages Post

The 505(b)(2) New Drug Application (NDA) pathway can provide unique advantages from the nonclinical development perspective that can save significant amounts of time, money, and resources. Compared to the... Read More

The Hypertension Fixed-dose Combination Product Guidance: Straight from the 505(b)(2) Playbook Post

The FDA just released a new draft guidance on developing fixed-dose combination antihypertensive products. While the clarification for industry is good, the strategy is not new to Camargo. Gaining approval of... Read More

Effects on Exclusivity: The Biologics Price Competition and Innovation Act of 2009 Post

On March 23, 2010, the U.S. FDA enacted the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as part of the Patient Protection and Affordable Care Act (Public Law 111-148). The passing of BPCIA... Read More

Use of Pharmacokinetic n(PK) Modeling & Steady-State Simulations in 505(b)(2) Drug Development Post

Sponsors and their investors continue to seek cost efficient ways to meet their financial milestones. Modeling can be used as a cost effective way to estimate the effect of changing an oral product from... Read More

Back to Basics: 505(b)(2) FAQs Part 4: Regulatory Strategies—Pharmacokinetic Studies Post

As the 505(b)(2) expert, Camargo is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Given the growing popularity of the... Read More

Optimizing Your Global Drug Development Program: Strategy for Regional Variations of the 505(b)(2) Pathway Post

At Camargo, we are often asked for strategic advice on drug development programs seeking approval in not only the United States (US), but also approval from other regulatory agencies, including the hybrid... Read More

The GRAS is Not Always Greener Post

The GRAS Is Not Always Greener: Why GRAS Status Does Not Guarantee Excipient Safety Many, if not most, 505(b)(2) submissions represent a change to an approved drug, usually involving a formulation change.... Read More

Orphan Drug Exclusivity for a Previously Approved Drug: a 505(b)(2) Conundrum Post

Until now, if a Sponsor intended to request orphan designation with 7 years of marketing exclusivity for a drug that has already been granted orphan designation, FDA has followed the Code of Federal Regulations... Read More

What is 505(b)(2) Page

What is 505(b)(2)? The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. Read more... Read More

Orphan Drug Development: Ensuring Best Time to Market Post

The Benefits of 505(b)(2) for Orphan Drug Development The Orphan Drug Designation Program, created by the Orphan Drug Act of 1983, provides significant financial incentives for the development of drugs for... Read More

Multiple Dosage Strength Products—CMC Considerations Post

Developing a product with multiple strengths? How do you go about filing multiple strengths in an IND? Lynn Gold, Ph.D., Camargo VP of CMC explains: How and when to draft one CMC section covering multiple drug... Read More

Is a Reference Listed Drug Mandatory in the 505(b)(2) Pathway? Post

If you are a frequent reader of our blog, you know that the 505(b)(2) pathway can facilitate a cheaper, faster drug approval route. This is accomplished by relying on: 1) safety and efficacy data from published... Read More

505(b)(2)s with Minimal Sponsor Studies Post

The power of the 505(b)(2) process is realized when the sponsor has to conduct few, if any, studies to get their drug product approved. For many drugs there is wealth of data available in the public domain. The... Read More

Colchicine Tablets Approved Post

Colchicine Tablets were approved by FDA on 7/29 & 7/30/09 (approval letters not yet posted as of this writing). Two NDA’s were submitted, one for the treatment of acute gout and the other for familial... Read More

Manufacturing Support for “Breakthrough Therapy—Designation for Solid Oral Dosage Forms Post

In November, this author participated in an open forum at the AAPS Annual Meeting focused on streamlining manufacturing and scale up to support ‘breakthrough therapy’ designation for solid oral dosage forms.... Read More

3-Year Exclusivity May Not Be Worth as Much as You Think Post

It is a widely held tenet that market exclusivity is essential for the successful launch of a new drug. But is this always the case? For products approved through the FDA 505(b)(2) pathway, is pursuing the... Read More

Pre-IND Meetings: The Increasing Frequency of Written Responses Only, and Which FDA Divisions Use Them the Most Post

Pre-IND Meetings: The Increasing Frequency of Written Responses Only, and Which FDA Divisions Use Them the Most The provision of Written Responses Only (WRO) by the FDA in response to Pre-IND meeting requests... Read More

Additional 505(b)(2) Benefits: Selective Safety Data Collection Post

Last month CDER/CBER released a short, final guidance*, “Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations.”* (CDER/CBER, 2016) While... Read More

What are DESI Drugs? Post

Once upon a time…. In 1938 the FD&C Act was established that required that drugs be proven safe before coming to the market. It wasn’t until the Kefauver-Harris Amendments to the Act in 1962 that drugs... Read More

Stability Requirements in the 505(b)(2) Space: Why, What, When, How Post

Stability Requirements in the 505(b)(2) Space: Why, What, When, How Hurry up and wait. That’s the seemingly eternal impact of developmental stability on the new drug development process. The question always... Read More

Electronic Submissions Update: End of FDA Paper Submissions Looms and What It Means Post

Electronic Submissions Update: the end of paper submissions looms closer, and requirements for Standardized Study Data go into effect: What that means for industry Under section 745A(a) of the FD&C Act, no... Read More

2008 505(b)(2) Approvals Post

For the first time, FDA’s new drug division has approved more 505(b)(2) drugs than those submitted via 505(b)(1). In 2006 and 2007, the percentage of 505(b)(2) drug approvals went from 20 to 43%, respectively.... Read More

Paper Submissions: Going, Going… Away Post

In order to fulfill a requirement specified in Section 745A(a) of the Food and Drug Administration Safety and Innovation Act (aka FDASIA), FDA recently issued a draft guidance directing mandatory use of... Read More

Gaining New Indications with Real World Data: The 505(b)(2) Sweet Spot Post

Gaining approval of new indications for approved or “old” drugs has always been one of the great advantages of the 505(b)(2) regulatory pathway. Couple that with the FDA’s recent enthusiasm for using real world... Read More

Get Your Pre-IND Meeting Done Right the First Time, and Other FDA Words of Wisdom Post

While the old adage “It’s easier to beg forgiveness than to ask permission” might have worked well as a child, it rarely applies when dealing with the FDA. The FDA recently published a final guidance titled... Read More

New (Draft) Guidance on Standardized Numerical Identification (SNI) for Drug Products Post

During drug development and/or during the review of a submission, FDA regulations may change. Changes can be made immediately or they can appear as drafts. Proposed regulations or guidances are presented in... Read More

What is an Approved DESI Product? Post

I am hesitant to contribute more information about so-called DESI drugs at the risk of further confusion. My goal is always to provide clarity, so here goes. Fundamental to any discussion about DESI products... Read More

Will We Have Generic User Fees? Public Meeting to Be Held. Post

On the new drug side we have had user fees since 1992. The Prescription Drug User Fee Act (PDUFA) has been renewed many times. The Act provides that FDA will adhere to certain goals in return for fees levied on... Read More

505(b)(2) Submissions: No RLD Post

Two weeks ago (10/14/09) I had the pleasure to present at the Drug Repositioning Summit in Boston. I started my talk by asking the audience if a 505(b)(2) application required a Reference Listed Drug (RLD).... Read More

Use of Extrusion-Enabled Pharmaceutical Processes in Drug Development via a Streamlined Regulatory Pathway Post

Extrusion-enabled pharmaceutical processing (E2P2) has long been employed in pharmaceutical development (Drug Development and Industrial Pharmacy. 33:909-926,1043-1057 (2007)). Reasons for utilizing E2P2... Read More

Labeling for Abuse-Deterrent Drugs Post

This past Tuesday (6/8/2010), we participated in a DIA-sponsored webinar entitled Understanding the Development and Label Allowances for 505(b)(2) Abuse-Deterrent Products. Joining me, Ruth Stevens our CSO and... Read More

What Clinical Studies Are Needed for a 505(b)(2) Drug Development Project? Post

On June 1, 2018, Camargo Pharmaceutical Services celebrated our 15th Anniversary. For this week’s blog, Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken... Read More

505(b)(2) for Formulation Changes Post

A couple of weeks ago I was invited to present at the 2009 Nebraska Research and Innovation Conference. The theme of my talk was “The Case for Improving Existing Drugs”. There are several factors driving... Read More

K-V’s Makena Part 2: Accelerated Approval Subpart H Post

In a previous posting, I provided background on KV’s Makena (17a-hydroprogesterone caproate injection aka 17P). The development and regulatory history contains many lessons. In this posting I’d like to examine... Read More

The Skinny On a Potential New Treatment of Obesity Post

Orexigen® Therapeutics is developing a new fixed dose sustained-release (SR) combination of naltrexone and bupropion for the treatment of obesity. The rationale behind the two active ingredients is stated to... Read More

FDA Warns P&G Over Use of Drug + Vitamin C Post

Last Thursday, 10/29/2009, FDA sent P&G a warning letter regarding Vicks DayQuil Plus Vitamin C and Vicks NyQuil Plus Vitamin C. The FDA takes the position that these two products are unapproved drugs... Read More

Does Europe Have a Pathway for Approval of Drugs Analogous to the FDA’s 505(b)2 Pathway? Post

As readers of this blog will know, a 505(b)(2) application is a US NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the... Read More

The Race to Get a Cannabidiol Product Approved: Why Is It Taking So Long? Post

Several companies have been competing to get the first cannabidiol product to market. Both investor and patient interest are high but the recent news includes more setbacks. What is different about cannabidiol... Read More

New Generic Stability Requirements Post

After much delay, FDA just released the new Guidance on the stability requirements to file and obtain approval of a generic drug product and API under 505j. The new requirements bring ANDAs closer in line with... Read More

Product Ideation: Who Wants to Develop a Successful Product? Post

As Sponsors become more aware of the benefits and risks of developing products in the current market, their focus often turns to Product Ideation and how this process can help develop smarter products. The... Read More

What Went Wrong? Important Outcomes of a Successful Pre-IND Meeting Post

We are pleased to present the second episode in a new format and series we’re adding to our 505(b)(2) Blog: a video blog / podcast called What Went Wrong? For our second episode, Ken Phelps, CEO, and Dr. Ruth... Read More

Navigating Clinical Holds Post

Sponsors spend countless hours developing Investigational New Drug (IND) applications, which are the US FDA’s regulatory gateways for conducting clinical trials of investigational drug and drug-device... Read More

Paragraph IV Certifications Under 505(b)(2) Post

What is the difference between a Paragraph IV certification between the 505j (ANDA, generic) and 505(b)(2)? None. The difference is the exclusivity outcome – 505(b)(2) never gets any exclusivity based on patent... Read More

A New Paradigm for the Development of Drugs for Type 2 Diabetes Post

Due to Camargo’s on-going client projects in this area, our chief medical officer, Dr. Sam Kaba recently attended a DIA-sponsored conference in Washington, D.C. entitled Cardiovascular Safety and Development of... Read More

Do Not Neglect Your Third-Party Drug Substance Manufacturer Post

Another example of the importance CMC was reported in January. Warner Chilcott plc received a complete response letter from the FDA. The “low dose” oral contraceptive NDA was the file in question. The FDA... Read More

Pediatric Assessments in Drug Development: Timing in Europe vs. US Post

As we have noted in this blog on several occasions, under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all new drug applications for a new active ingredient, new indication, new dosage form, new... Read More

FDA Regulatory and Strategic Development Case Study Page

To learn how Camargo's combination drug-device and target market knowledge created commercial success, read this FDA regulatory and strategic development case study. Read More

P&G Drops Out of a 505(b)(2) Development Post

Nastech announced on 11/7/2007 that P&G had dropped out of their co-development of a nasally delivered version of Lilly’s osteoporosis drug Forteo (teriparatide). As reported, the Nastech CEO speculated... Read More

Don’t Launch Unapproved Products After 9/19/2011 Post

I had a call from a client who wondered if he could launch a new ‘DESI’ product. He had just read the FDA’s recent announcement that it would take immediate enforcement action on any unapproved drug introduced... Read More

REMS in Congress Post

I’m not into politics, but maybe some of my readers are and wish to contact their representative in the U.S. House of Representatives to share your thoughts on a pending issue. With the introduction of REMS,... Read More

Drug Repositioning Summit 2008 Post

Camargo was one of the sponsors of Cambridge Healthtech Institute’s Drug Repositioning Summit last week (Oct. 6-7, 2008). I woke the group up on the second day with a breakfast talk entitled “505(b)(2)... Read More

What’s the Competition? Post

In speaking with prospective clients, we often discuss the potential competition to their proposed drug product. In order to have success in the market, the proposed product needs market differentiation. Some... Read More

Pre-IND Meetings: How to Achieve Success for 505(b)(2) Post

One of the greatest mistakes that the Sponsor of a 505(b)(2) can make is to have an unsuccessful Pre-IND meeting. Common errors occur at the Pre-IND meeting because Sponsors and CROs that are more familiar with... Read More

Test Specifications for Stability Studies Post

Pivotal stability programs that are used to generate stability data for NDA submissions are different than research stability programs used to design the drug product, explore packaging configurations, etc.... Read More

Strategic Submission Case Study Page

To learn how Camargo course-corrected a client’s NDA package to gain drug approval, read this strategic submission case study. Read More

The New FDA Draft Guidance on Chewables Post

An idea for a more convenient dosage form for an existing drug product often presents an opportunity for a commercial advantage. Fortuitously, it also presents the possibility for using the 505(b)(2) regulatory... Read More

Morphine Sulfate Oral Solution-Roxane is First Across the 505(b)(2) Finish Line Post

Although morphine sulfate oral solution has been used for many years in pain management, it had never been approved by the FDA. As part of their ongoing unapproved drugs initiative, the FDA announced on March... Read More

The 505(b)(2) Approval Pathway Provides Opportunities for Generics Companies Seeking New Revenue Streams Post

The “cliff” has passed for pharma but has just begun for generics companies that have benefited from the high number of drugs going off patent. CEOs of generics companies report they are considering a spectrum... Read More

How Much Is a First Cycle Review ANDA Approval Worth to You? Post

At the recent GPhA meeting in Orlando, Florida, Dr. Kathleen Uhl from the FDA Office of Generic Drugs (OGD) spoke about the quality of Abbreviated New Drug Application (ANDA) submissions and highlighted the... Read More

Reference Listed Drugs (RLDs): Can More Than One Be Used? Post

Recently we considered the case of a 505(b)(2) NDA without an RLD. So let’s ask if a 505(b)(2) NDA have more than one RLD? In a word, the answer is “yes”! When using the 505(b)(2) regulatory pathway, Sponsors... Read More

How Will New FDA Guidance for Generic Abuse-Deterrent Opioids Pan Out?—An Update Based on the Final Guidance Post

With a recent update from the United States Food and Drug Administration (US FDA), the quest for abuse-deterrent opioids has taken another step. But will the new Guidance lead developers forward or... Read More

Cheerios®: Breakfast Cereal or Drug? Post

Cheerios® – venerable breakfast cereal or…drug? Last month the FDA issued a warning letter to General Mills CEO Ken Powell, informing him that the cholesterol-lowering claims on the Cheerios label transformed... Read More

Shortening the Review Clock: the Latest on Priority Review Vouchers Post

The Latest on Priority Review Vouchers Priority review vouchers (PRVs) are a valuable incentive available to companies upon approval of novel drugs to treat rare pediatric diseases or certain tropical... Read More

MannKind Breathes Easier—Inhaled Insulin Finally Approved Post

MannKind’s Afrezza Receives FDA Approval In June of this year, MannKind Corporation announced that they received FDA approval for Afrezza®, their rapid-acting inhaled insulin product. MannKind is currently... Read More

Why Generic Companies Might Like 505(b)(2) Post

How would you like to spend a couple of hundred thousands of dollars (or equivalent local currency) and countless months getting FDA approval and patent expiration and then face 14 competitors? What’s the ROI... Read More

Active Ingredients vs. Active Moieties—Perplexity of Understanding the Relationship or Distinction Post

Recently a federal district court spotlighted FDA’s apparently inconsistent definitions of what constitutes an “active ingredient (AI)” in rejecting the Agency’s rationale for denying Amarin Pharmaceuticals... Read More

Complete Response Letters (CRLs): Big Trouble for Small Pharma Post

A Complete Response Letter (CRL) can have a devastating effect on a small company’s share value, as evidenced by the recent examples of Recro Pharma and Cosmo Pharmaceuticals. A recent EP Vantage analysis of... Read More

505(b)(2) Approval Times: The Real Scoop Post

The Approval Time for 505(b)(2) and 505(b)(1) NME Products Is Similar A recent article by the Tufts Center for the Study of Drug Development (summarized here) reported that approval times for New Molecular... Read More

Due Diligence Assessment: Determining a Drug Product’s Potential Value Post

The risk involved with an asset needs to be assessed before a sale. Whether from the buy or from the sell side, it pays to understand how much an asset is worth. For those involved with in-licensing or... Read More

The Target Product Profile: Your Strategy to Reduce Development and Review Time Post

Time and again, we see a case of a drug being developed, approved, and launched, only to flop in the marketplace. There are varying reasons for these market launch failures, but one reason, reliably, is the... Read More

FDA’s Determination of Vyvanse as NME Upheld Post

On March 4, 2010 the U.S. District Court for the District of Columbia agreed that FDA was within its rights to grant Shire’s Vyvanse (lisdexamfetamine dimesylate) NME status and thus, 5-years exclusivity. New... Read More

Risk Evaluation Mitigation Strategy (REMS) for Long-Acting Opioids Post

Camargo is working with several clients in developing better treatments for pain. Unfortunately, the active substances that supress pain also can be abused. The FDA and DEA are trying to find ways to allow... Read More

The Shutdown from Camargo’s Perspective Post

Now that the FDA has received at least a temporary reprieve from the longest government shutdown in history, we thought we would share some background and a timeline, along with our experience during the... Read More

505(b)(2) NDA Labeling Post

All NDA submissions require that a draft label be included. For a 505(b)(2) NDA, where do you get the information for this label? What labeling is required? What is labeling? Well, the “label” is what is on... Read More

Getting Cannabis-related Products Approved: the 505(b)(2) 4-20 Projects Post

Several states in the US have already passed laws that remove state restrictions on the medical use of marijuana and its derivatives, and more states are considering such action. The market for medical... Read More

Tropical or Rare Pediatric Disease Priority Review Vouchers: Update and Use of the 505(b)(2) Pathway Post

Tropical or Rare Pediatric Disease Priority Review Vouchers: Update and Use of the 505(b)(2) Pathway While the United States market for drugs and biologics targeting tropical or rare pediatric diseases is very... Read More

Examining the Amarin VASCEPA Saga Post

The headlines and newscasts reported Amarin’s success in wining off-label promotion, but behind the scenes, another noteworthy action took place – in a very rare action, the FDA rescinded a special protocol... Read More

Not a Generic? Must Be a 505(b)(2)? Post

Generic or 505(b)(2)? The Office of Generic Drugs (OGD) receives many applications under 505(j) that do not meet the statutory definition of a generic drug. The applications reference an approved drug (the... Read More

Failed 505(b)(2)?: Vivus™ Qnexa Post

I am often asked about 505(b)(2) drug development failures. After all, 505(b)(2) is a regulatory pathway that is chosen because it is lower cost and has lower risk than a 505(b)(1). The lower risk is... Read More

The Regulation of Follow-On Biological Products via 505(b)(2) Post

Strike While the Iron is Hot In December 2015, the U.S. FDA granted approval for Eli Lilly and Company’s Basaglar (insulin glargine injection), a long-acting human insulin product indicated for glycemic... Read More

Special Protocol Assessment: Is It Important for Your Drug Development Program? Post

The overarching goal of the Special Protocol Assessment Draft Guidance for Industry May 2016 (HHS, FDA, CDER, & CBER) is to improve the quality of new drug applications (NDAs) and biologic license... Read More

Key Questions You Must Ask Before Hiring a Drug Development Consultant Post

Drug development consultants worldwide promise many things. Traditionally, biotech and pharma companies hire consultants to help guide them through the regulatory process or to fill in where their own companies... Read More

Importing Investigational Pharmaceuticals to the U.S.? Changes Are Coming Post

Importing Investigational Pharmaceuticals to the U.S.? Changes Are Coming The United States government is making ongoing, concerted efforts to improve the importation process for many products, including... Read More

FDA Firsts and Updates: Competitive Generics, Complex Generics, SiRNA Approval, and Closing the Orphan Loophole Post

We decided to mention some noteworthy firsts from the FDA during August 2018 and a change in the FDA’s policy on obtaining orphan incentives via pediatric-subpopulation designation. Competitive Generic... Read More

Improving Drug Development ROI in 2017 Post

Time to Pick the Low-Hanging Fruit: Improving Drug Development ROI in 2017 With forecasts of decreasing peak sales for late pipeline drugs, a logical way to increase the return on investment (ROI) for... Read More

ANDA but No NDA—What to Rely On? Post

Camargo participates in 2-5 PIND meetings each month and one thing we notice in the FDA minutes is that the boilerplate answer to ‘does the Agency agree this ….. is appropriate for filing under 505(b)(2)?’... Read More

K-V’s Makena®: A trove of 505(b)(2) Lessons Post

On February 3, 2011 Hologic, Inc. (subsequently sold assets to KV Pharmaceuticals) received 505(b)(2) approval of Makena®, its 17?-hydroxyprogesterone caproate injection (17P) to reduce the risk of preterm... Read More

Nuedexta®—Smart Pharmacology to Treat a Unique Disorder Post

The FDA has approved NuedextaÃ’ (Avanir Pharmaceuticals Inc.), a drug that curbs involuntary and uncontrolled crying and laughing episodes (known as pseudobulbar affect (PBA)) that are experienced by patients... Read More

REMS/ETASU and Safe Use in Bioequivalence Trials Post

We’ve previously commented regarding the predilection of RLD holders whose product approvals include a Risk Evaluation and Mitigation Strategy (REMS) and Elements To Assure Safe Use (ETASU) to use the... Read More

Lannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j? Post

Lannett Co., Inc. and its subsidiary Cody Laboratories manufacture Morphine Sulfate Immediate Release Concentrated Oral Solution 20mg/mL. Readers will remember that the various manufacturers of morphine... Read More

A New Indication for an Old Drug. What Could Go Wrong? Post

Desmopressin (DDAVP®; Ferring Pharmaceuticals Inc) was approved in the US in 1978. DDAVP is currently approved to treat central diabetes insipidus, hemophilia A, type 1 von Willebrand’s disease, nocturnal... Read More

Drug Repositioning: 2 Flavors Post

Last week’s Drug Repositioning Summit was attended by more than 150 people. The Summit started with my 3-hour workshop on 505(b)(2) drug development. Several attendees were seemingly confused about what “drug... Read More

Use of Data from Foreign Clinical Studies for US Approval Post

Two major factors drive clients to consider running trials in foreign countries – cost and recruitment. The question we often get is: can we use the data from such trials in a US submission? The answer is:... Read More

505(b)(2) Approvals for 2017: What Were They and Who Developed Them? Post

Our last blog gave the numbers on 505(b)(2) approvals in 2017, including orphan designations and priority review products. Here we take an in-depth look at what kind of products were approved via the 505(b)(2)... Read More

What is an NME? Post

People are often surprised when I tell them that 505(b)(2) applications can contain a new molecular entity (NME). In fact, a 505(b)(2) covers any NDA application that relies on pivotal efficacy or safety... Read More

505(b)(2)—Freedom from Generic Competition—Exclusivity Issues Post

Well, freedom from generic competition for a while at least. Generally, most companies business plans specify some means to keep the competition at bay until the product can make a profit : when revenues start... Read More

REMS or RiskMAP or What? Post

On 30 September 2009, the FDA issued a new draft guidance for industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications. The... Read More

505(b)(2) Patent & Marketing Exclusivity Post

IP attorney Stephen Albainy-Jenai and I just concluded a webinar hosted by DIA entitled 505(b)(2) Patent & Exclusivity. 23 different companies attended, showing the increasing interest in 505(b)(2) issues.... Read More

Nonclinical Bridging—Most 505(b)(2)’s Don’t Require Full Tox Package Post

I have just finished a webinar under the sponsorship of the DIA dealing with non-clinical bridging. In this post, I’d like to share one of the case studies from my presentation to illustrate what should be... Read More

Nonclinical Study Requirements for 505(b)(2) Development Post

On June 1, 2018, Camargo Pharmaceutical Services celebrated our 15th Anniversary. For this week’s blog, Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken... Read More

PRO-CTCAE: Improving Oncology Drug Development Post

Patient-reported outcomes (PROs) provide valuable tools for collecting information on subjective symptomatic effects during clinical trials. They are considered the gold standard for the assessment of... Read More

Pediatric Applicability or Not—This Revised Guidance is for You Post

Since 1994, the statutory and regulatory requirements for drug product labeling for pediatric populations have been evolving. The FDA Modernization Act of 1997 (FDAMA) contained incentives for conducting... Read More

Prodrug Denied Post

I am frequently asked if 505(b)(2) projects fail or whether any NDA submissions are rejected. My answer is that the vast majority succeeds and are eventually approved. Those that fail more often are due to... Read More

Target Product Profile Post

Today’s blog courtesy of Lynn Gold, Ph.D. Camargo’s VP of CMC. In any project development program an understanding of the program goal is critical to finding the shortest path to the final result. Generation... Read More

Back to Basics: 505(b)(2) FAQs Part 1 Post

As the 505(b)(2) expert, Camargo is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Given the growing popularity of the... Read More

On the “Fast Track”: Fast Track Designations for Your 505(b)(2) Drug Development Program Post

To expedite products where there is the greatest clinical need, the FDA offers 4 expedited programs to get beneficial therapies to patients faster: Priority Review, Accelerated Approval, Breakthrough Therapy... Read More

Market Assessment: Post

A lot of our focus in previous blogs has been on how to best negotiate regulatory hurdles to get your product approved as quickly and cheaply as possible, and how to differentiate your product from the marketed... Read More


Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


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  • ent-examples-and-advantages" class="flex items-center"> 505(b)(2) Nonclinical Development: Examples and Advantages Post The 505(b)(2) New Drug Application (NDA) pathway can provide unique advantages from the nonclinical development perspective that can save significant amounts of time, money, and resources. Compared to the... Read More

    Proposed FDA Rule Would Make Sponsors More Responsible for Data Integrity: Way More Responsible Post

    On February 19th, 2010, FDA published a proposed rule in the Federal Register to revise 21 CFR §§ 16, 58, 71, 101, 171, 190, 312, 511, 571 and 812 to require Sponsors of the various impacted regulatory... Read More

    A New Paradigm for the Development of Drugs for Type 2 Diabetes Post

    Due to Camargo’s on-going client projects in this area, our chief medical officer, Dr. Sam Kaba recently attended a DIA-sponsored conference in Washington, D.C. entitled Cardiovascular Safety and Development of... Read More

    505(b)(2) for Formulation Changes Post

    A couple of weeks ago I was invited to present at the 2009 Nebraska Research and Innovation Conference. The theme of my talk was “The Case for Improving Existing Drugs”. There are several factors driving... Read More

    505(b)(2)—Freedom from Generic Competition—Exclusivity Issues Post

    Well, freedom from generic competition for a while at least. Generally, most companies business plans specify some means to keep the competition at bay until the product can make a profit : when revenues start... Read More

    Questions and Answers on the Topic of Authorized Generics Post

    What would be the regulatory path for an Authorized generic, in general? Authorized Generics (AG) are prescription drugs that are produced by the NDA holder and marketed under a private label, at generic... Read More

    Does Europe Have a Pathway for Approval of Drugs Analogous to the FDA’s 505(b)2 Pathway? Post

    As readers of this blog will know, a 505(b)(2) application is a US NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the... Read More

    Benzyl Alcohol—NME Approved Under 505(b)(2) Post

    The source of NMEs (new molecular entities) for use in 505(b)(2) drug development programs is vast. A major benefit of an NME is the 5 year data exclusivity. Sciele Pharma recently (4/9/09) obtained 505(b)(2)... Read More

    New FDA Guidance Illustrates Breadth of 505(b)(2) Development Programs Post

    It is clear the FDA recognizes the range of development possibilities made possible by the 505(b)(2) pathway, as illustrated by the recently released draft guidance for the development of depot buprenorphine... Read More

    505(b)(2—Part 3: Pre-IND Submission & Meeting Post

    Before filing an IND, it is desirable (we counsel imperative) to have a pre-IND meeting with the FDA. The goal is to get FDA’s concurrence with the proposed development plan and regulatory submission pathway.... Read More

    The Winding Path to De-Risking Formulation Changes Post

    Originally posted by AAPS Blog 10/7/15 If you are a researcher involved in drug development, you are familiar with the inevitability of change and the need to manage and understand it throughout the... Read More

    Importing Pre-Launch Products with a Bit of PLAIR Post

    With the tsunami of activities connected with the initial implementation of all the GDUFA requirements, another change made by FDA went largely under the radar. FDA released the draft guidance, “Pre-Launch... Read More

    K-V’s Makena Part 4: Statistical versus Clinical Significance Post

    In previous postings (Intro, Part 1, Part 2, Part 3), I have provided background on KV’s Makena (17a-hydroxyprogesterone caproate injection aka 17P). The development and regulatory history contains many... Read More

    Approvals of ANDAs Slows Post

    I attended the 2011 Generic Pharmaceutical Association (GPhA) meeting last week. There was lots of useful information from several speakers. One area in particular stood out to me — the approvals of ANDAs are... Read More

    Market Assessment: Post

    A lot of our focus in previous blogs has been on how to best negotiate regulatory hurdles to get your product approved as quickly and cheaply as possible, and how to differentiate your product from the marketed... Read More

    MannKind Breathes Easier—Inhaled Insulin Finally Approved Post

    MannKind’s Afrezza Receives FDA Approval In June of this year, MannKind Corporation announced that they received FDA approval for Afrezza®, their rapid-acting inhaled insulin product. MannKind is currently... Read More

    505(b)(2) Literature Searches—Too Much or Too Little? Post

    A 505(b)(2) submission relies on information in the public domain to fulfill some of the information required in an NDA for approval. This information comes from more than the reference drug’s NDA review... Read More

    The Race to Get a Cannabidiol Product Approved: Why Is It Taking So Long? Post

    Several companies have been competing to get the first cannabidiol product to market. Both investor and patient interest are high but the recent news includes more setbacks. What is different about cannabidiol... Read More

    5-Year Exclusivity for Certain Fixed-Combination Drugs with an NCE Post

    The FDA recently posted new Guidance on its website awarding certain fixed-combination drug products (fixed-combinations) 5-year new chemical entity (NCE) exclusivity. While the Agency held previously that... Read More

    Don’t Let Pre-Approval Inspections and the Drug Approval Process Stall Your Application Post

    On May 27th, 2016, AstraZeneca announced they received a Complete Response Letter (CRL) from the FDA for their sodium zirconium cyclosilicate (ZS-9) New Drug Application (NDA) (reference link). This... Read More

    ANDA but No NDA—What to Rely On? Post

    Camargo participates in 2-5 PIND meetings each month and one thing we notice in the FDA minutes is that the boilerplate answer to ‘does the Agency agree this ….. is appropriate for filing under 505(b)(2)?’... Read More

    Brexit and EMA: The Changes Have Begun Post

    After months of speculation, the first round of changes for pharmaceutical manufacturers arising from the planned withdrawal of the United Kingdom of Great Britain and Northern Ireland (UK) from the European... Read More

    2008 505(b)(2) Approvals Post

    For the first time, FDA’s new drug division has approved more 505(b)(2) drugs than those submitted via 505(b)(1). In 2006 and 2007, the percentage of 505(b)(2) drug approvals went from 20 to 43%, respectively.... Read More

    Target Product Profile Post

    Today’s blog courtesy of Lynn Gold, Ph.D. Camargo’s VP of CMC. In any project development program an understanding of the program goal is critical to finding the shortest path to the final result. Generation... Read More

    Colchicine Tablets Approved Post

    Colchicine Tablets were approved by FDA on 7/29 & 7/30/09 (approval letters not yet posted as of this writing). Two NDA’s were submitted, one for the treatment of acute gout and the other for familial... Read More

    Endpoint for GI Toxicity Clarified Post

    NSAIDs are known to induce gastrointestinal (GI) tract toxicity, notably upper GI tract. Drugs that suppress gastric acid secretion such as histamine type 2 receptor antagonists, proton pump inhibitors (PPIs),... Read More

    3-Year Exclusivity May Not Be Worth as Much as You Think Post

    It is a widely held tenet that market exclusivity is essential for the successful launch of a new drug. But is this always the case? For products approved through the FDA 505(b)(2) pathway, is pursuing the... Read More

    PREA Requirements for Biosimilar and Interchangeable Biological Products Post

    In general, under the Pediatric Research Equity Act (PREA), submission of an initial pediatric study plan (iPSP) is required for a drug or biological product that includes a new active ingredient, new... Read More

    What is an Approved DESI Product? Post

    I am hesitant to contribute more information about so-called DESI drugs at the risk of further confusion. My goal is always to provide clarity, so here goes. Fundamental to any discussion about DESI products... Read More


    Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


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