Last night, the FDA published the Generic Drugs Program Monthly and Quarterly Activities Report for February 2026 (here). As has been the case lately, there is both good and bad news. Let’s look at the highlights of the report. First, let’s look at the approval metrics. The OGD fully approved 64 ANDAs; of that number, […]
The ongoing GDUFA IV negotiations have shed some light on interesting issues that will apply to the new GDUFA reauthorization period for FYs 2028 to 2032 presently being considered by both industry and the FDA. The full minutes of the February 19, 2026 FDA-industry negotiation meeting can be found here, but I have a brief summary of the […]
Through March 16, the Office of Generic Drugs has issued 30 full approval actions and 7 tentative approval actions. This appears to be about the average number of mid-month approval actions totals we have seen for this current fiscal year. With fewer ANDAs being submitted, it is not clear to me why the approval actions […]
While endotoxin and pyrogen testing might not be the sexiest of topics, they are extremely important topics for creating a safe sterile product. I believe that FDA has made your job easier by their recent publication of the guidance titled Pyrogen and Endotoxins Testing ‒ Questions and Answers (Edition 2) yesterday (here). It contains a […]
The FDA has finalized the Guidance for Industry titled Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (here). The final guidance is essentially the same as the draft of the same name issued on October 22, 2022 with the exception of minor editorial changes to increase clarity. The use of classic […]
In a pre-publication notice in the Federal Register today, the FDA published OTC manufacturing facility fees for Fiscal Year 2026. The fees are due on June 1, 2026. There are two types of OTC manufacturing facilities outlined in the statute: First is the OTC Manufacturing Drug Facility (MDF), which is described as “a foreign or domestic […]
The FDA announced (here) that it has approved leucovorin calcium for “cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential for brain health) transport into the brain. Individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive […]
Just one too much controversies, just too many career FDAers’ decisions overridden, just too much change to vaccine recommendations, and, apparently, just one too many changes in previously agreed-upon requirements have led to the second departure of Vinay Prasad from the position of Director, Center for Biologics Evaluation and Research. Commissioner Makary announced that Prasad […]
Today, the FDA issued a draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection (here). The pre-publication Federal Register notice (here) indicates that the stated purpose of the guidance “is to assist manufacturers who choose to respond to FDA when they receive an FDA Form 483 Inspectional Observations (FDA 483) […]
February was a short month with a big number as the OGD issued 64 full-approval actions and 25 tentative-approval actions for a total of 89 approval actions. This represents both the highest number of approvals thus far this fiscal year and the most total approval actions since January 2025, when there were 90. With ANDA […]
