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 […]
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 […]
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 […]
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 […]
Deflecting responsibility is a timeless tactic for the young. While it was easy to simply point the finger and say, “I didn’t do it, they did,” as children, this approach is not viable in the life-sciences industry when things go awry. In this sector, we can’t simply transfer our responsibilities without written agreements and clear […]
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 […]
There were a lot of great speakers at Access 2025, the Association for Accessible Medicines (AAM) annual meeting held from February 3rd to 5th. Here are a few of some of the most interesting topics that were discussed in fireside-chat formats. John Murphy III, President and CEO of AAM, posed questions to Alex Azar, former Secretary, […]
Powered up my laptop this morning and guess what I found? ANDA, NDA, and BLA approval actions had been updated from their last postings on January 22, 2025 after the pause on communications from the FDA. The best news is that January 2025 ANDA approval actions look great. As of today, the OGD has posed 64 […]
