The Generic Drug Forum was a two-day event held on April 8-9, 2025. This was one of the first public engagements that the Office of Generic Drugs (OGD) participated in since the current administration’s pause on FDA communications was announced in February 2025. There were many interesting sessions that presented an enormous amount of content. […]
Presentations for the Generic Drug Forum, which was held in person and virtually on April 8-9, provided a look at the Office of Generic Drugs’ compliance with Fiscal Year (FY) 2024 User Fee goals for review of applications and supplemental applications. The OGD has met all of its review objectives from the GDUFA commitment letter for […]
Trust is essential to everything we do in the pharmaceutical industry. Developing new drugs requires speaking the global language of data, which is meaningless without trust. Toxicity, efficacy, bioequivalence, and bioavailability are key measurements of drug safety and effectiveness, all spoken in the language of data. These only have meaning if there is trust. Imagine […]
It has been quite some time since issuance of the GDUFA III commitment letter, which discussed a few new enhancements to the ANDA review and approval process, among other things. One such enhancement was Imminent Action (IA). Just to refresh your memory, an imminent action is an extension of the goal date when the Office of […]
On April 10, U.S. Senators Maggie Hassan (D-NH), Rand Paul (R-KY), John Hickenlooper (D-CO), and Mike Lee (R-UT) reintroduced bipartisan legislation S. 1302 that would prevent the FDA and industry from participating in a protracted guessing game regarding the amount of an inactive ingredient for a subset of generic drugs that are either required by regulation […]
So, after Monday’s blog post, All’s Quiet On the Eastern Front (here), I woke up this morning to the first signs of at least some normality at the OGD. First, ANDA approval numbers began appearing on the Daily Approvals page and the Small Business and Industry Assistance webpage. On top of that, the first day […]
We have posted several blogs about the uncertainty regarding how the FDA staff cuts could impact business as usual with the FDA (see posts here, here, and here). Kurt Karst, Director at Hyman, Phelps & McNamara, posted a blog today (here) that dives into the “eradication” of the Division of Policy Development in the Office […]
Given all that’s happened with the federal government this past week, it’s no wonder that we’re not hearing much from the OGD. Communications appear to be quite slow to appear. Even the Federal Register prepublication page has few FDA postings over the last three weeks. Another instance of communication lapse: since March 7, 2025, only safety […]
April Fool’s Day was a difficult day for many FDA employees, because that was when many of them found out they were let go as they attempted to enter FDA’s White Oak HQ by swiping their badges at the entry gates. With many significant Offices and Division cuts, there are questions of how those cuts […]
On March 28, the FDA issued a notice (here) informing pharmaceutical companies that have submitted in vitro and in vivo bioequivalence studies in applications that were conducted by Raptim Research Pvt. Ltd., a contract research organization (CRO) based in Navi Mumbai, India, that it has “identified significant data integrity and study conduct concerns” in certain studies in […]
