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 […]
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 […]
A recent report in Nature Medicine (published February 17, 2025) highlights the long-term potential of Chimeric Antigen Receptor T Cell products (aka CAR-T cell therapy), showcasing an exceptional 18-year remission in a neuroblastoma patient. This milestone is particularly significant given the historical challenges that CAR-T therapy has faced in effectively treating solid tumors like neuroblastoma, even while […]
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, […]
“Disruption” was the common theme expressed by many panel members at this year’s Access 2025 meeting of the Association for Accessible Medicines in Amelia Island, Florida. In speaking to attendees, “I just don’t know what to expect” seemed to be the mantra of the day. The absence of FDA attendees also seemed to shake the […]
In the quest for effective treatments for their disease, cancer patients often require several different modalities and treatment types. Radiopharmaceutical products are one of those forms of treatment, and treatment with these types of products requires expedient delivery to ensure that the required dosage is administered to patients as radioactive decay may result in a […]
There are a few items I’ve seen that give me hope that the communications ban may be coming to an end soon. However, there are still some mysteries in the ban that confuse me. For instance, there have been no approvals listed on the CDER webpage (here) since January 22, 2025. But today, for the first […]
