Draft DMF Guidance Issued by FDA

A new draft guidance titled (quite originally) Drug Master Files (here) has replaced the Drug Master Files: Guidelines that was published in 1989.  There have been many changes to the requirements and procedures for DMFs based on new laws, policies, and procedures, as well as procedures associated with GDUFA commitment letters for ANDAs,

First Official Metrics Out for September and OGD Smashes FY ANDA Approval Record – Could It Have Been Better?

For the first time since GDUFA’s beginning, the number of ANDA approval actions exceeded the number of ANDAs received in a given FY (935 approvals vs 909 new ANDA receipts). In addition, OGD smashed the FY approval record with the 935 approval actions by 154 (or 16.5%) more than the previous record of 781 in FY 2018. 

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New FDA Guidance on PDUFA Fee Waiver, Reductions, and Exemptions Issues

It has been a while since the FDA updated its guidance on PDUFA fee waivers, etc., but the newly released Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products document provides much needed new information about the FDA’s fee program.  The Federal Register Notice (here) announcing the availability of the guidance states:

“This guidance describes the types of waivers,

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E-Cigarettes – What Will Be Their Fate?

In thinking about the current vaping issues, which have been associated with a significant number of deaths and hundreds, if not thousands, of lung-related injuries, I think the path to the future of these products needs to be critically evaluated by the FDA.  The introduction of e-cig came so fast that the FDA was not prepared to deal with the issue. 

Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development

Aloka Srinivasan, Vice President, Regulatory Practice at Lachman Consultants recently wrote an article for PharmTech, detailing the Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development. The article provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in the API or [...]
Old Way x New Way Crossroad

Are All Methods Equivalent?

The use of alternate methods, especially for USP methods, some of which are rather old, has long been a question that both the industry and the FDA have contemplated.  Alternate methods can be easier to use and, in some instances, more accurate and reliable.  But how can you demonstrate that an alternate method is indeed equivalent to an existing method?

Lachman Consultants to Show a Large Presence at the 2019 ISPE Annual Meeting & Expo

(Westbury, NY – October 2019) Lachman Consultant Services, Inc. (“Lachman Consultants”), a leading provider of expert compliance, regulatory affairs, and technical services to life sciences organizations worldwide, will return to the International Society for Pharmaceutical Engineering’s (ISPE) 2019 Annual Meeting. Lachman Consultants is sponsoring the event on October 27-30 and will be located in booth [...]
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California Governor Got it Wrong on Pay-for-Delay!

While California is usually a very progressive state, I believe that Governor Newsom did not quite understand the implications of the bill he signed into law banning pay-for delay patent settlements.  I believe he failed to see that not all pay-for-delay cases are anticompetitive.  According to the Association of Accessible Medicines (AAM) statement about the bill:

“As the Federal Trade Commission has found,

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OGD Updates August 2019 Metrics

August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications.  Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review applications submitted each month. 

Just Say No! Not a Good Idea for a Testing Lab

In a short Warning Letter issued by the FDA on August 29, 2019, the Agency informed a China-based testing firm that, because it refused inspection, that FDA would withhold approvals of any ANDA or NDA in which it was cited as a testing laboratory.  The FDA takes refusal of inspection very seriously and the impact on NDA or ANDA sponsors (or,

Vasopressin Verdict May be Precedent for Drug Companies Seeking to Protect Approved Products

In his article “Endo comes out on top in its fight with FDA and bulk compounder” published in Fierce Pharma (here), Eric Palmer has pointed to a potentially precedent-setting decision that may have further implications for the outsourcing compounding community.  The FDA has a long-standing policy regarding the marketing of unapproved drugs after the first approval through an NDA process.