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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

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

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

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

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

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)—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


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


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Headquarters
9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
800 Taylor Street
Suite 101, Mill No. 1
Durham NC, 27701
Montreal Office
507 Place d'Armes
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Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
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Contact
Headquarters
9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
800 Taylor Street
Suite 101, Mill No. 1
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
Fax 513.561.3367
Subscribe for our Latest Insights
s" class="btn-inline">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

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

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) 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

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

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

US Generics: FDA Policy Changes, Growing use of 505(b)(2), and Supply Shortages; Topics from a Roundtable Discussion Media

Publication: Bernstein Research, AllianceBernstein

Date: March 17th, 2014

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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

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

2013 505(b)(2) NDA Approvals Post

2013 appears to be a challenging year for FDA NDA approvals. FDA’s John Jenkins reviewed the NME NDA and BLA approvals through November 2013, showing that 25 such products were approved (see chart below). These... 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
800 Taylor Street
Suite 101, Mill No. 1
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights
ex items-center"> 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

PREA—Pediatric Plan Timing Changed by PDUFA V Post

The Food and Drug Administration Safety and Innovation Act (FDASIA; also known as PDUFA V), signed into law on July 9, 2012, contains amendments to the Pediatric Research Equity Act (PREA) that specifically... Read More

Polypill: a 505(b)(2) Candidate Post

FDA approved Novartis’ Exforge HCT on April 30, 2009 for the second-line treatment of hypertension. Exforge, approved in 2007, contains the calcium channel blocker amlodipine and the angiotensin receptor... 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

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

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

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

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

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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Camargo Vice President of CMC Services Leads 505(b)(2) Roundtable and CMC Focus Group at 2012 AAPS Annual Meeting Media

Date: October 10th, 2012

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Why 505(b)(2) is a Whole Different Animal Media

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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

The 505(b)(2) Forum to Feature Successful Methodologies and Technology Approaches Media

Publication: The 505(b)(2) Forum

Date: October 14th, 2014

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

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Understanding the 505(b)(2) Approval Pathway Media

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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

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

Article: Camargo, Ken Phelps, and 505(b)(2) in Korean publications Media

Date: December 11th, 2017

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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

Camargo Uses 505(b)(2) to Fast-Track Indian Products Media

Date: July 24th, 2012

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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

Merck Uses 505(b)(2) for New Combo Post

On May 3, 2013 FDA approved Merck’s Liptruzet, which combines the its Zetia (ezetimibe) and atorvastatin – Pfizer’s Lipitor which has gone generic. According to the Merck press release, Liptruzet was approved... 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

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

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

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

Regulatory Scientist Career Posting

Location: Multiple states

Type: Full Time

Minimum Experience: Entry Level

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Residual Solvents—New FDA Draft Guidance Post

The USP established a new test requirement for control of residual solvents in finished dosage forms. The new test is in the General Chapter “Residual Solvents” [Sorry no link – password protected].... 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

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

Why have a Quality Overall Summary for the Quality Module? Post

The Quality Module (Module 3 or Chemistry, Manufacturing and, Controls section (CMC)) in the eCTD format serves as the backbone of any regulatory submission, an IND or NDA. We have discussed this in a previous... 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

Using Product Ideation to Achieve Commercial Success Webinar

This webinar is beneficial for investors and executives at Biotech and Pharma companies interested in increasing portfolio value through Product Ideation, an often-overlooked creative process utilizing the... 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

Botanicals: What is the Starting Material for the API? Post

We typically work with small molecules of synthetic origin, but occasionally are retained to work with products that have active ingredients from botanical (plant) sources. Lynn Gold, our VP of CMC provides the... Read More

Early 505(b)(2) Strategy for Long-term Success Webinar

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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

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), Why Now? With Hands On the Project Case Study Webinar

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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

Camargo Pharmaceutical Services and FDA to Share 505(b)(2) Expertise at 2015 AAPS Annual Meeting and Exposition Media

Date: October 14th, 2015

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Camargo Celebrates 10 Years with the 505(b)(2) Pathway Media

Date: October 24th, 2013

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New User Fees for 2011 Post

FDA announced the new PDUFA user fees for fiscal year 2011 (starts October 1, 2010). The fee for a full application containing clinical data is $1,542,000. For a supplement or an NDA not requiring clinical... Read More

Generic Companies Look to the 505(b)(2) Application Process to Speed Up Product Approvals Media

Publication: Outsourcing-Pharma, William Reed

Date: September 24th, 2013

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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

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

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

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

Scorecard of FDA Approvals Added Post

I have added a new page to this blog to track 505(b)(2) approvals. Please note the tab named Scorecard. It will be organized by calendar year. I am currently catching up on 2009 to date. Enjoy and give... Read More

Camargo President and Vice President Lead 505(b)(2) Symposium and CMC Focus Group at 2011 AAPS Annual Meeting Media

Date: November 14th, 2011

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US Generics: FDA Policy Changes, Growing use of 505(b)(2), and Supply Shortages; Topics from a Roundtable Discussion Media

Publication: Bernstein Research, AllianceBernstein

Date: March 17th, 2014

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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

Whitepapers Page

Review our industry-leading whitepapers on pharmaceutical development and commercialization. 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

Identifying Products for Drug Development Programs Media

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Aequus Partners with Camargo to Support US Regulatory Strategy for Development Programs Media

Publication: Aequus Pharmaceuticals Inc., via Market Wired

Date: October 3rd, 2016

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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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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

Strategies for Pharmaceutical Development in China Media

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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

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

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

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

Cocoon Biotech Announces Partnership with Camargo Pharmaceutical Services for Development Programs Media

Publication: Cocoon Biotech; Camargo Pharmaceutical Services, via PR Newswire

Date: February 2nd, 2017

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PCID Summary Post

The FDA issued a draft guidance “Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers (PCID) into Solid Oral Dosage Form Drug Products for Anticounterfeiting” on July 13, 2009. This PCID... 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

Brand Name Drugs No Better Than Generics Post

Read the headline again – ‘Brand-name drugs no better than generics’. This headline was on MSNBC/MSN web site and originated from a Reuters article reporting on a study conducted by Dr. Aaron Kesselheim of... 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

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

Scott Cain Leadership Team

Dr. Cain has more than 20 years of management experience in preparing, editing, and overseeing the production of a full range of clinical research and regulatory documents in support of drug development... Read More

Camargo Hires Rick Bell to Lead Business Development Media

Date: November 28th, 2007

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

Date: May 22nd, 2012

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Camargo Adds VP Clinical Development & Chief Medical Officer, Samer E. Kaba, MD Media

Date: February 3rd, 2009

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BIO—User’s Manual Post

I attended the 2008 BIO Annual convention, my first. More than 20,000 registrants. There were the usual plenary sessions with lots of wonderful, flowery, well-meaning platitudes and well-deserved awards. The... 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

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

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

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

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

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

CNN Story on “Unapproved Drugs” Post

CNN ran a story today to increase public awareness that there are hundreds of drugs consumed in the U.S. that have never been formally approved by the FDA. For professionals, the FDA has a web page devoted to... Read More

DESI Presentation: Q&A Post

Today I conducted an audio conference entitled: FDA banning DESI Drugs-Submissions Strategies to Keep Yours on the Market. I know, a bit aggressive, but it’s also a crowded market. Judging from the questions,... Read More

FDA Approves Xanodyne’s Tranexamic Acid Post

Xanodyne obtained 505(b)(2) approval for tranexamic acid for use in treating heavy menstrual bleeding (menorrhagia). The RLD is Cyklokapron(R) which is used to treat hemophilia and to reduce the need for... 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

PhRMA and GPhA Team Up (!) to Offer their EAR Proposal to Solve Generic Safety Labeling Issue Post

FDA held a public hearing this past Friday (27March2015) to air their proposal that generic companies be responsible for updating their labeling whenever ‘new safety information’* is available. Generic... Read More

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

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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

Quivive Pharma Partners with Camargo Pharmaceutical Services for Development Programs Media

Publication: Camargo Pharmaceutical Services, via PR Newswire

Date: May 4th, 2017

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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

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

Second Annual 505(b)(2) Forum to Discuss Product Development, Regulatory Updates, and Recent Court Cases Media

Date: October 22nd, 2015

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The 505(b)(2) Forum in Israel Will Review Case Studies and Strategies for 505(b)(2) Approval Pathway Media

Publication: The 505(b)(2) Forum

Date: April 14th, 2015

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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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Lumosa Therapeutics Partners with Camargo Pharmaceutical Services in the Development of Naldebain(R) in the US Media

Publication: Lumosa Therapeutics, Markets Insider

Date: August 28th, 2017

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Aequus Announces Abbreviated Development Path for Transdermal Aripiprazole Media

Publication: Aequus Pharmaceuticals, Markets Insider

Date: August 24th, 2017

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Global Health Solutions Partners with Camargo Pharmaceutical Services for Onychomycosis Development Program Media

Publication: Global Health Solutions, via PR Newswire

Date: August 21st, 2017

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The Camargo Way Page

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

Cingulate Therapeutics Partners with Camargo Pharmaceutical Services for Development Programs Media

Publication: Cingulate Therapeutics, via PR Newswire

Date: August 8th, 2017

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505(b)(2)—No Patent, Just Exclusivity Post

We have all been confronted with the issue of patents and exclusivity for 505(b)(2) product development projects. Financial backers, VC’s, private equity are fixated on the ruggedness of patents – no patent =... 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

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

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

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

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

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

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

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

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

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

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

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

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

Demystifying Orange Book Designations: The New Referencing Approved Drug Products in ANDA Submissions Draft Guidance Post

Since its first appearance in 1980, the Approved Drug Products With Therapeutic Equivalence Evaluations publication (commonly referred to as the Orange Book) has served as a gateway for the emergence of generic... 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

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) 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

Strategy Page

Whether requiring help with FDA requirements or approval phases or exploring product opportunities, Camargo has product strategy offerings to set you on the path to success. 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

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

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

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

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

The Camargo Story Page

Through expert pharmaceutical manufacturing consulting, Camargo is passionate about accelerating access to medicines that address global patient needs, enhance quality of care, and improve health outcomes. 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

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 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

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

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

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

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

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

2013 505(b)(2) NDA Approvals Post

2013 appears to be a challenging year for FDA NDA approvals. FDA’s John Jenkins reviewed the NME NDA and BLA approvals through November 2013, showing that 25 such products were approved (see chart below). These... 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

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

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

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

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

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

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

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

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

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

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

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

Process & Benefits Page

Drawing on our extensive understanding of the medication development process, Camargo creates and implements unique, customized programs matched to specific needs. Read More

Ken Phelps Leadership Team

In 2003, Ken Phelps applied more than three decades of industry experience to found Camargo Pharmaceutical Services in Cincinnati with Dr. Ruth Stevens (chief scientific officer and executive vice president).... 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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) 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

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

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

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

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

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

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

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

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

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

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

Is Your Drug Project a 505(b)(2), ANDA or OTC? Post

I get a lot of requests to assure people that their project is, or is not, a 505(b)(2). A few questions about whether it is an OTC candidate. The question about whether the proposed drug is a 505(b)(1) or 505... 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Regulatory Strategy Director Career Posting

Location: Multiple states

Type: Full Time

Minimum Experience: Experienced

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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

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

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) Approvals Post

I have seen various postings and articles on the number of 505(b)(2) approvals. The numbers do not always agree. Why don’t they agree? Many people look only at the approval letter. The FDA will always indicate... 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

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

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

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

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

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

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

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) Combination Meets Phase 3 Goals Post

Horizon Therapeutics announced yesterday that its “fixed-dose combination product containing ibuprofen and famotidine, demonstrated a statistically significant reduction in the incidence of non-steroidal... Read More

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

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

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

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

Quick-release Bromocriptine Mesylate Approved Post

The FDA approved VeroScience’s Cycloset (bromocriptine mesylate) 0.8mg tablets on May 5 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The NDA was first... 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

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

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

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

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

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

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

Blog & Resources Page

Camargo brings you the latest pharmaceutical development and commercialization resources and news. 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

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

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

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

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

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

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

2010 505(b)(2) Approvals Post

We join everyone else this time of year and develop a list – ours is a 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

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

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

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

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

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

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

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

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

Biovail to Reduce 505(b)(2) Development Post

Biovail joined the increasing list of pharma companies that are downsizing or eliminating their 505(b)(2) development programs. As reported in the Wall Street Journal* Biovail CEO William Wells, in a... 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

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

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

Camargo Blog Page

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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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What Went Wrong? Make Sure Your Bridge Stays Intact, CMC and Dissolution Post

Make Sure Your Bridge Stays Intact: CMC and Dissolution in 505(b)(2) Development One of the most common reasons for a company developing a drug to receive a Refuse to File letter from the FDA is for problems... 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

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

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

Thank You Page

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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
800 Taylor Street
Suite 101, Mill No. 1
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights
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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The 505(b)(2) Forum to Feature Successful Methodologies and Technology Approaches Media

Publication: The 505(b)(2) Forum

Date: October 14th, 2014

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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
800 Taylor Street
Suite 101, Mill No. 1
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights