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of CVM Guidance for Industry (GFI) #42 “Animal Drug Manufacturing Guidelines – Series of Four Guidelines,” which was withdrawn in October 2019, the animal health industry has been anticipating guidance from the CVM on these topics.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 […]
Since the implementation of the CARES Act reporting requirement, the question continues to be asked: Is it really a requirement? The answer is yes, and now it is no longer recommended, but is stated as “should” in the newly published Final version of the Guidance for Industry (GFI) “Reporting Amount of Listed Drugs and Biological […]
In Part 1, we focused on drafting the Controlled Correspondence and tips for formatting and presenting the correspondence, but, after submission, the CC must be accepted by the coordinator to be placement in the queue for review. The office has been very strict, perhaps rightly so, but there have been a few headscratchers too. Some examples […]
For those struggling with understanding all the complexities of running a 503B compounding facility, a new resource is now available. The International Society of Pharmaceutical Engineers (ISPE) has a new guide coming out titled “503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities” (here). Do you know why compounding exists? Shouldn’t all […]
Of the many benefits that have come from the Generic Drug User Fee Act (GDUFA) over the years, one has been the addition of response times for the FDA to answer Controlled Correspondences (CCs) that were first negotiated under GDUFA II. The Agency issued an FDA CC guidance, which was finalized in December 2020. Having a […]
