On Day 2 of the Generic Drugs Forum (GDF), there were a couple of sessions on Drug Master Files (DMFs) that provided some helpful information. The first presentation, from Dr. Jayani Perera, Senior Chemist in the Division of Product Quality Assessment (DPQA) XIX, provided some insight into the GDUFA III impact on DMF Assessments and DMF Prior Assessments (watch […]
On Day 1 of the Generic Drug Forum, the topic of submitting a Request for Reconsideration (RfR), as first provided for in GDUFA II and updated in GDUFA III, was presented. The FDA’s Office of Generic Drugs (OGD) had two presentations on this topic, one from Joe Shin, PharmD, and one from Dr. Yi Zhang. In his presentation, Dr. Shin […]
Revision 2 of the FDA Guidance for Industry “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” was published on January 6, 2025 and it finalizes the previous draft version. This is a procedural guidance that applies to medical products regulated by CDER, CBER, CDRH, […]
If you received one or more reminder emails in November 2024 asking your firm to submit 2023 CARES Act reports, you are not alone. In 2024, the FDA emphasized the importance of CARES Act reporting and the Agency’s need for the data contained in those reports at several conferences, but there have continued to be […]
Rounding out the User Fee announcements, the Over-the-Counter Monograph Drug User Fee Program (OMUFA) announced its FY 2025 fees on July 31, 2024. The Federal Register Notice announcing the new fees can be found here. The update was only to the OTC Monograph Order Request (OMOR) fee rates – it did not include an update for the […]
With the development of new technologies and drugs, the need for certain products to be presented as combination products for administration is becoming more and more commonplace. According to the FDA FAQs page on Combination Products (here), “Combination products are typically marketed under a marketing authorization type associated with the constituent part that provides the […]
At the Center for Drug Evaluation & Research (CDER) Small Business Industry Assistance (SBIA) meeting held on April 25th, titled “Facilitating Generic Product Availability Through Product-Specific Guidances (PSGs) for 2024,” the FDA presented some updates regarding the FDA Dissolution Database. Dr. Leah Falade, Senior Pharmacologist in the Office of Pharmaceutical Quality, CDER, was the presenter in Session 6. […]
For anyone who wishes to gain a better understanding of all the complexities of running a 503A compounding pharmacy, a new resource is now available. The International Society of Pharmaceutical Engineering (ISPE) recently published a new Guide titled “Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies” (here). Some of you reading […]
What is the answer to the question? Apparently, at the FDA’s Center for Drug Evaluation and Research (CDER) Small Business Industry Assistance (SBIA) Generic Drug Forum for 2024 (held April 10-11), it was Controlled Correspondence (CC). The FDA conducted two presentations exclusively on CCs and responded with that answer on more questions than not throughout […]
Since the retirement of CVM Guidance for Industry (GFI) #42 “Animal Drug Manufacturing Guidelines – Series of Four Guidelines,” which was withdrawn in October 2019, the animal health industry has been anticipating guidance from the CVM on these topics. The first of four anticipated guidance documents was issued on March 18, 2024 as a draft (here), and […]
