In what has been a rather strange pattern of ANDA approval actions in May, the OGD has issued 36 full-approval actions and 5 tentative-approval actions in the first fifteen days of the month, which is a good result. However, the daily approval pattern seems a bit strange. On May 2nd, the OGD issued 9 full-approval […]
While we were able to piece together the April 2025 unofficial approval picture, we need to note that it has now been over three months since any official statistics from the Generic Drugs Program Monthly and Quarterly Activities Report have been published publicly (see here). This is a bit discouraging, but not totally unexpected, after […]
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 […]
With the first (albeit unofficial) count of ANDA approval actions since the layoffs at the OGD, the future does not appear bleak. At least not yet! The postings through April 16th for approval actions show that the OGD has issued 43 full-approval actions and five tentative-approval actions for a mid-month total of 48 approval actions, which […]
Lachman has blogged many times on the topic of nitrosamines over the last several years as the FDA has issued and revised guidances providing its recommendations for assessment and control of nitrosamine impurities. The published deadline for compliance with these recommendations is quickly approaching; it’s just over three months until the August 1, 2025 compliance date […]
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 […]
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 […]
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 […]
