Ingestible fluoride products used to prevent dental caries have a long and twisted regulatory history relative to their permitted marketing status. After searching the web for an explanation, I found an interesting article (here) published by the Fluoride Action Network. I provide this article as it gives a reasonable historical account of the avenues along which the […]
Over the last eight months, a number of priority vouchers were sold by firms that were subject to the award of either a tropical disease priority review voucher, a rare pediatric disease priority review voucher, or a material threat medical countermeasure (MCM) priority review voucher. The purchase prices of these vouchers, while not as high […]
We just wrapped up an engaging and insightful two days (May 6-7, 2025) at the PDA Pharmaceutical Manufacturing and Quality Conference 2025 in Singapore. As anticipated, the event delivered high-value content through impactful presentations from current and former regulators as well as seasoned industry professionals. Their thoughtful responses to audience questions added real depth to the […]
The FDA completed its first AI-assisted scientific review pilot, which will provide reviewers with great opportunities for efficiency in the review process. According to the FDA release (here), Dr. Makary said, “I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount […]
As a refresher, a reference listed drug (RLD) product for which sale has been discontinued or for which the firm has withdrawn its approval for commercial reasons and that was relied upon as the basis for submission of an ANDA creates a regulatory problem for firms that have approved ANDA versions or drug products with […]
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 […]
Today, the FDA announced the “Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities” (here), signaling that the Agency appears to be leveling the playing field between domestic and foreign facility inspections. According to the comments in the May 5, 2025 Regulatory Affairs Professionals Society (RAPS) Regulatory Focus article by Joanne S. Eglovitch (here), the “unannounced foreign […]
Biological Product Deviation Reports (BPDRs) are coming into increasing focus during FDA inspections. The FDA commonly requests an understanding of a site’s BPDR process and examples of BPDRs submitted to the Agency. Furthermore, during the inspection and during evaluation of distributed licensed product, FDA investigators will evaluate “How,” “Why,” and “When” a firm determines the […]
Talk has come fast and furious about a new, significant FDA reorganization with what looked like, as reported by PharmaVoice’s Amy Baxter (here), “five new shared services offices rather than the current product-based offices.” However, in an exclusive interview with Dr. Marty Makary that was conducted by Jeremy Faust, MD and reported in Inside Medicine (here), […]
With the FDA declaring the shortage of semaglutide over and the recent development that “U.S. District Judge Mark Pittman denied the Outsourcing Facilities Association’s bid for a preliminary injunction that would have prevented the FDA from taking action against its members for making copies of semaglutide, the active ingredient in Ozempic and Wegovy” (see here), […]
