29
Jun
Close up of female student study using handbooks writing notes

REMS – Revision 2 Adds Updates to Previous Two Versions

The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2.  Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]

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08
Jun

Data Integrity Issues Still Plague Pharmaceutical Manufacturers – Where’s the Beef?

I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems […]

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28
May

Meeting and Application Goal Dates – Questions and Answers of Impact of COVID-19 Work

The FDA released a guidance to remain in effect until the COVID-19 public health emergency is resolved titled Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers ( here).  In this guidance, the Agency addresses many questions they have been asked about scheduling meetings, face-to-face (FTF) […]

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06
May
Businessman examines a tablet with a magnifying glass. Concept of internet security

Getting Ready for FY 2021 PDUFA Program Fees – “Dear Colleague” Letter Arrives in the Mail

The FDA has sent a “Dear Colleague” letter (here) to NDA holders to get ready for the start of FY 2021 on October 1, when the program fees (previously called “product fees” in previous iterations of PDUFA) will be due for each product (up to 5 in each application) marketed by the application holder.  The […]

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22
Apr
Lightning strike from a thunderstorm

Jump in Number of Clinical Trials for COVID 19 Treatments Explodes

In a post entitled The Path Forward: Coronavirus Treatment Acceleration Program (here) penned by FDA Commissioner Steven Hahn, CBER M.D., Director Peter Marks, M.D., Ph.D., and CDER Director Janet Woodcock, M.D., the FDA describes the accelerated actions the Agency is taking to move the most promising therapeutic treatments to patients as quickly as possible. Just […]

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09
Apr

COVID-19 and Shortage-Related Requests for Manufacturing Process and Site Changes

On April 7, 2020, FDA released a Q&A on manufacturing and supply change requests related to COVID-19 and drug shortages.  In this Q&A, FDA provided the following guidance:   Manufacturing site changes because of supply chain disruptions related to COVID-19 – If the site change is for treatment of patients with COVID-19 or for drugs […]

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07
Apr
world map, creative abstract design background photo

How Do Bad Facts Become Fake News and Possibly Worse?

Oftentimes, we hear startling statistics that make us shiver and can cause a knee jerk reaction.  Much has been written about the quantity of drugs that come from overseas, and the push for moving manufacturing of active pharmaceutical ingredients (API) and finished dosage forms (FDF) back into the U.S.  While bringing jobs back to the […]

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01
Apr

CTAP Program to Accelerate COVID-19 Drug Development and Approval

  Today, the FDA announced (here) its Coronavirus Treatment Acceleration Program (CTAP), which is designed to use “every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”  The FDA will continue to enhance this emergency program to bring safe […]

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23
Mar

FDA to Exercise Enforcement Discretion for Certain Limited REMS ETASU Elements

Another FDA Guidance entitled Policy for Certain REMS Requirements During the COVID19 Public Health Emergency (here) provides another look into the complexity of the questions and the situations that arise when we are in the throes of a public health emergency (PHE) and the interplay of existing FDA requirements in addressing urgent need during the […]

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