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Results for: prodrug


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

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

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

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

Deuterization: Is it Enough to Get 5- or 7-Year Exclusivity for a 505(b)(2) Product? As the 505(b)(2) experts, Camargo has received several enquiries about developing deuterated drugs as a means of achieving... 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

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

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 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The FDA just released a new draft guidance on developing fixed-dose combination antihypertensive products.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

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

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

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

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

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

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

Did FDA Make a Mistake? Prodrug Emend Exclusivity Reconsidered Post

It is important to give the FDA credit for admitting mistakes. Yesterday’s posting in this blog concerned Vyvance’s NCE and 5 year exclusivity status. The thorough response by the FDA to the Actavis request... Read More

FDA Reaffirms 5-year Exclusivity for a Prodrug Post

FDA has reaffirmed its prior assignment of 5 years exclusivity to Vyvance (lisdexamfetamine dimesylate). When Vyvance was approved in 2007, this prodrug of dextramphetamine was given NCE status with a 5 year... 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

505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success, Q&A Part 1 Post

Earlier this month, Camargo President and Co-founder, Ken Phelps, held a webinar 505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success with Fierce Biotech. Because of the great questions... 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

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

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

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


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


Contact
Headquarters
9825 Kenwood Road,
Suite 203
Cincinnati, OH 45242
Durham Office
2505 Meridian Parkway,
Suite 150
Durham, NC 27713
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights
l> "/resources/blog/get-your-pre-ind-meeting-done-right-the-first-time-and-other-fda-words-of-wisdom" class="btn-inline">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

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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

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

2017—A Great Year for Generics—Yes or No? Post

Generic Firms Looking for Revenue with 505(b)(2) AAM’s Annual Conference is over and most of the generic companies are glad 2017 is over, too. Despite media reports that 2017 was the best year ever for... 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

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

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

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

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

Roche’s Actemra Approved for RA After Year’s Delay Post

John Jenkins, Office of New Drugs Director, remarked on the low rate (30 percent) of firstcycle approvals for standard review applications (‘The Pink Sheet,’ Dec. 7, 2008). He attributed the low approval rate... 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

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

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

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

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

Priority Review Vouchers are a Big Carrot for Hungry Companies Post

Priority review vouchers (PRVs), which are fast-becoming a powerful incentive for drug companies, were originally based on a publication (Ridley et al. 2006) from a group at Fuqua School of Business at Duke... Read More

Quality Metrics—Coming Soon to Your Manufacturing Facility Post

In the July 28th, Federal Register, (Under “Meetings”) FDA announced the availability of the draft guidance “Request for Quality Metrics-Guidance for Industry.” Although there are “requests” for quality metrics... 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

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

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

Culture & Careers Page

Find meaning in your work through pharmaceutical jobs and careers in medicine. Camargo is passionate about accelerating access to medicines that address global patient needs, enhance quality of care and improve health outcomes. 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

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

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

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

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

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

A New Indication for an Old Drug. What Could Go Wrong? Desmopressin (DDAVP®; Ferring Pharmaceuticals Inc) was approved in the US in 1978. DDAVP is currently approved to treat central diabetes insipidus,... 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

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

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

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

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

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

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

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

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

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

Orphan Designation without Exclusivity: Court Asked to Decide Post

Yesterday, Depomed filed suit against the FDA requesting the Court to order FDA to grant their product Gralise (gabapentin) 7 years of exclusivity since it was granted Orphan status; upon approval, Gralise was... 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

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

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

505(b)(2)—Part 2: The Assessment: CMC Development Plan Post

CMC Development Plan All too often we see plans that don’t integrate the clinical trial materials with the clinical development plan. This is usually because the people and organizations responsible for each... 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

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

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

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

Market Assessment: Is Your Product Going to Make It on the Market? 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

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

Scope of Orphan Drug Exclusivity—How Broad is Broad? 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

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

21st Century Cures Act—Provisions Impacting Pharmaceutical Regulation Post

On July 2, 2015 the House passed the 21st Century Cures Act . The focus is on expediting research and development on debilitating diseases, and smoothing the process to get important therapeutic options to... Read More

Encounters of the Third Sector Post

As I walked the floor at the International Generic Pharmaceutical Alliance (IGPA) conference in Toronto, I couldn’t help but feel a little gratified. Companies that were once disavowing the 505(b)(2) approval... Read More

Are 505(b)(2)’s “Super Generics” or What Do We Call Them? Post

When we started Camargo almost 10 years ago, products approved under 505j were called ‘generics’ and 505(b)(1) ‘new drugs’. We could find no consensus of a name for products approved via 505(b)(2). Of course,... Read More

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

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

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

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

One of the tenets of the FDA is to get safe and effective drugs to market as soon as possible. To expedite products where there is the greatest clinical need, the FDA offers 4 expedited programs to get... 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

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

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

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

Regulatory Strategy Director Career Posting

Location: Multiple states

Type: Full Time

Minimum Experience: Experienced

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


Contact
Headquarters
9825 Kenwood Road,
Suite 203
Cincinnati, OH 45242
Durham Office
2505 Meridian Parkway,
Suite 150
Durham, NC 27713
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights
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

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

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

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

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

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

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

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

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

Back to Basics: 505(b)(2) FAQs Part 2: Clinical and Nonclinical 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Recent Developments for Abuse-Deterrent Opioids: FDA and Payers Influence Societal and Market Impact The requirements for abuse-deterrent opioids are in flux as the FDA grapples with what they can do to... Read More

FDA Product Development and Regulatory Consultant Case Study Page

To learn how Camargo's expert use of data from outside sources saved a project, read this FDA product development and regulatory consultant case study. Read More

Use of Foreign Trial Data Post

No, I don’t have a crystal ball. Yesterday, I posted comments on the factors FDA can use to determine what foreign trial data it can use (extrapolate) to US populations and medical practice. Today, an article... 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

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

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

Analytical Requirements for Oral Solutions Post

Analytical requirements for the NDA submission of an oral solution to the FDA are very similar to those requirements for any new drug product. The analytical methods that are used for the testing of an oral... 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

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

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

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

Quality Metrics—Coming Soon to Your Manufacturing Facility Post

In the July 28th, Federal Register, (Under “Meetings”) FDA announced the availability of the draft guidance “Request for Quality Metrics-Guidance for Industry.” Although there are “requests” for quality metrics... 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

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

FDA Action on Exparel® Highlights the Importance of Letting the Data Drive the Story Post

The recent key decision by the FDA for Exparel® stresses the importance of reevaluating 505(b)(2) strategy throughout a product development lifecycle. A solid, data-driven development strategy is important from... 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

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

21st Century Cures Act—Provisions Impacting Pharmaceutical Regulation Post

On July 2, 2015 the House passed the 21st Century Cures Act . The focus is on expediting research and development on debilitating diseases, and smoothing the process to get important therapeutic options to... 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

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

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

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

Totality of Evidence and 505(b)(2): Are Two Phase III Studies Too Many for a Well-Known Already-Approved Drug? Post

Totality of Evidence and 505(b)(2): Are Two Phase III Studies Too Many for a Well-Known Already-Approved Drug? As the 505(b)(2) expert, Camargo is exposed to many projects in which Sponsors have attempted to... 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

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

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

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 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

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

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

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

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

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

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

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

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

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

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

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

505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success, Q&A Part 1 Post

Earlier this month, Camargo President and Co-founder, Ken Phelps, held a webinar 505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success with Fierce Biotech. Because of the great questions... 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

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

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

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

For centuries, botanical remedies have been used in many cultures to treat various diseases. In recent years, pharmaceutical companies have turned to botanical drugs for alternative medicines to treat diseases... Read More

Stability Changes Coming to ANDAs Post

This post comes from D.C. where I am attending the GPhA Fall Technical Conference. We just completed a presentation by FDA’s Glen Smith. He detailed the proposed new stability requirements for ANDA drug... Read More

Adams “DESI” Product Approvable Post

Adams Respiratory Therapeutics announced that it received an Approvable letter from FDA on 10/29/07 for its guaifenesin 600/1200 mg and codeine phosphate 30/60 mg extended-release bi-layer tablets. The release... 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

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

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

“Breakthrough” the Barriers: Breakthrough Therapy Designation for 505(b)(2) Post

“Breakthrough” the Barriers: Breakthrough Therapy Designation Will Speed Up the Development and Review Time for Your 505(b)(2) Product Breakthrough Therapy Designation (BTD) is the most recent addition to 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

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

Inactive Ingredients Exposed Post

You’re choosing excipients and determining amounts, so you go to the IAG (Inactive Ingredient Guide) look up the approved amounts and you’re good to go. Right? Maybe not… You need to consider EXPOSURE.... 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

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

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

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

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

Culture & Careers Page

Find meaning in your work through pharmaceutical jobs and careers in medicine. Camargo is passionate about accelerating access to medicines that address global patient needs, enhance quality of care and improve health outcomes. Read More

Priority Review Vouchers are a Big Carrot for Hungry Companies Post

Priority review vouchers (PRVs), which are fast-becoming a powerful incentive for drug companies, were originally based on a publication (Ridley et al. 2006) from a group at Fuqua School of Business at Duke... 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

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

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

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

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

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

Roche’s Actemra Approved for RA After Year’s Delay Post

John Jenkins, Office of New Drugs Director, remarked on the low rate (30 percent) of firstcycle approvals for standard review applications (‘The Pink Sheet,’ Dec. 7, 2008). He attributed the low approval rate... 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

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

AB Rated 505(b)(2)’s Post

Can you have an “AB” rated 505(b)(2)? Yes, as well as other Therapeutic Equivalent (TE) codes that are most often associated with the TE codes for generics in the Orange Book. Several years ago when I was... 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

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

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

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

Deuterization: Is it Enough to Get 5- or 7-Year Exclusivity for a 505(b)(2) Product? As the 505(b)(2) experts, Camargo has received several enquiries about developing deuterated drugs as a means of achieving... 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

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

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

A New Indication for an Old Drug. What Could Go Wrong? Desmopressin (DDAVP®; Ferring Pharmaceuticals Inc) was approved in the US in 1978. DDAVP is currently approved to treat central diabetes insipidus,... Read More

Suicidal Behavior: Ignore Therapeutic Area at Your Own Risk Post

We hope a common theme emerges from this blog and our public interactions: it is vital when planning 505(b)(2) drug development to look at the entire therapeutic class to learn what studies are needed for... Read More

Market Assessment: Is Your Product Going to Make It on the Market? 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

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

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

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

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

Is There a Market for Your Drug? Post

At Camargo, we can help clients evaluate the market potential of their proposed drug product by examining factors that might influence the resulting medical position at the time of product launch. When desired... 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

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

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

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

Modeling Using Dissolution Data Post

Not only pharmacokineticists get to have fun in the modeling sandbox. Chemists and formulators get to have their fun synthesizing data. Let’s use an example of how dissolution data can be used for modeling. 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

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

PK Modeling, Not Just Any Pretty Face Post

We recently changed the navigation and look of our website to show that we are a full-service drug development company. 505(b)(2) drug development is so much more than just regulatory submissions! I was asked... 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

One of the tenets of the FDA is to get safe and effective drugs to market as soon as possible. To expedite products where there is the greatest clinical need, the FDA offers 4 expedited programs to get... Read More

2012 PDUFA User Fees Post

The 2012 PDUFA User Fees have been announced in the Federal Register. In summary, the fees are: Applications: Full – requiring clinical data (e.g., Phase 2 or 3): $1,841,500 Not requiring clinical data :... 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

Just a BE Study for 505(b)(2) Approval? Likely Not! Post

I have addressed this topic before but from several recent discussions I thought it useful to repeat this here. A number of companies hope to do just BE studies to obtain approval. The proposed changes to the... Read More

$1,247,200 PDUFA Fees for FY 2009 Post

FDA announced on August 1, 2008 the user fees for fiscal year 2009 (the U.S. government 2009 fiscal year start on October 1, 2008). The fees are based on PDUFA IV approved last year. The application fee for an... 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


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


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