The Lachman Blog

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05
Jul

OGD Updates May 2018 Statistics

OGD updated its monthly Activities Report Of the Generic Drug Program FY 2018 for certain statistics that had not yet been posted (here). While we wait for the June 2018 official approval and receipt figures, let’s have a look at some of the interesting May statistics. OGD reported 8 refuse-to receive (RTR) actions, with an […]

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04
Jul
Amendments, business and law concept. Folder Register on desk

Final Guidance on ANDA and Supplement Amendments Hits the Newsstands

Today, as a 4th of July present, and in anticipation of celebratory fireworks, the FDA has issued a final guidance entitled ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA (here).  The final guidance explains that the complex tiered amendment classification system of GDUFA I was abandoned to provide a less cumbersome and […]

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03
Jul

Outsourcing and Compounding Pharmacies Under FDA Scrutiny for Topical Pain Products, But That’s Not All

FDA Commissioner Scott Gottlieb issued a statement (here) on the Agency’s continuing position related to compounded drugs for patients that cannot use an FDA approved product.  However, the bent taken in his statement leans more towards the issues of safety and efficacy, while he points to the Department of Justice’s (DOJ) recent healthcare fraud enforcement […]

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02
Jul
Goal Solution Concept on Blackboard

GDUFA II Regulatory Science initiative – AAM Provides Good Advice

On June 25, 2018, the Association of Accessible Medicines (AAM) submitted comments to Docket FDA-2017-N-6644: Generic Drug User Fee Amendments Reauthorization of 2017; Regulatory Science Initiatives; Public Workshop and provided some very interesting and relevant comments and suggestions.  The full text of the AAM comments can be found here, but here is a peek into […]

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29
Jun
Quality Concept: Arrow of A Compass Pointing Quality Text

Quality Metrics- The Next Step

Over a decade ago, the FDA issued a final report on Pharmaceutical Quality for the Twenty-First Century. As time moved forward, this led to the FDA’s Center for Drug Evaluation and Research through the creation of the Office of Pharmaceutical Quality, to launch “FDA Pharmaceutical Quality Oversight: One Quality Voice” (here), which attempts to develop […]

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21
Jun
Waiver legal concept

Update of 2011 Draft Guidance on Waivers, Reductions, and Refunds of PDUFA Fees

The revised version of the 2011 Draft Guidance (here) “describes (1) the types of waivers, refunds, and reductions available under the user fee provisions of the FD&C Act, (2) the procedures for requesting waivers, refunds, or reductions, and (3) the process for requesting a reconsideration, or appeal of an FDA decision.  The Draft Guidance also […]

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20
Jun

CDER Outlines Actions on Drug Shortages

Late yesterday, Dr. Douglas Throckmorton, Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, issued a statement on the FDA’s ongoing efforts in the area of drug shortages.  Based on our post yesterday (here), which outlined the FDA’s new report on drug shortages for 2017, we felt it was necessary […]

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