Almost two months to the day, the OGD published its final December statistical report along with the Quarterly Report on approval times for the first three months of FY 2025. It appears that the OGD did better in ANDA approval and tentative approval (TA) actions than we had reported back on January 6, 2025 in […]
Each year about this time the FDA sponsors an Advisory Committee meeting to flush out the best guesses of experts on what would be the best composition of next season’s flu vaccines. MSN reports (here), “[T]he annual meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is crucial for drugmakers to ensure […]
There is a hint that the “pause” or freeze on communications from the FDA may be starting to thaw. This morning, a CDER Small Business and Industry Assistance (SBIA) Webinar titled Navigating Controlled Correspondences to Support Generic Drug Development, to be held on February 27, 2025 from 1:00 to 3:30 p.m., was posted with a request […]
Not too long after Patrizia Cavazzoni, M.D. left the FDA as Director of the Center for Drug Evaluation and Research (CDER), according to Drew Armstrong’s article in Endpoints News (here, subscription required), she landed at Pfizer where she was hired as Chief Medical Officer. She had worked at Pfizer previously and left the Agency shortly […]
According to one of the few Federal Register (FR) notices we have seen relating to FDA activities, today’s pre-publication page of the FR notes that “[i]n accordance with the memorandum of January 20, 2025, from the President, entitled ‘Regulatory Freeze Pending Review,’ the effective date of the final rule entitled ‘Food Labeling: Nutrient Content Claims; Definition […]
In the Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy) issued by the FDA on February 21, 2025 (here ), the Agency indicates that the supply of the innovator products either meet or exceed demand for Semaglutide Injection products. While the FDA acknowledges that there may be some patients that continue […]
Even though it is February 21, 2025, we are only reporting ANDA approval actions posted through February 14, 2025, because approval actions have been slow to post on the daily approvals listing on the FDA web site, possibly impacted by the pause in the FDA communications imposed by the new administration. Thus far, through February […]
At the Association for Accessible Medicines (AAM) Annual Meeting (aka Access! 2025), the Science and Regulatory Affairs Working Group met on February 3, 2025. This session is always a highlight, and one of my favorite sessions, offering insight into key regulatory and scientific issues that the AAM is currently tackling as well as those that it […]
I guess this is the next step in the evaluation of what we can expect regarding proposals for future regulations. Semiannual regulatory agendas, along with tentative timetables, are published twice a year (as the name implies) to outline regulations that each agency is planning on issuing for those regulations. Today, in the pre-publication of the […]
Because of my history of close association with various FDA Centers and Offices over my time at the FDA, as well as thirty years consulting for the industry and interacting with the FDA, I can’t help but think about our colleagues at the Agency. It has been reported that there has been a significant brain […]
