FDLI’s 2026 annual conference covered several industry hot topics, with a particular focus on AI and how the FDA is leveraging technology and existing resources to improve efficiency and engage with industry. Although progress appears to be on the horizon, industry should remain mindful of the FDA’s current structural limitations and the ongoing need for […]
Dr. Marty Makary resigned today as FDA Commissioner, marking another leadership transition for an agency that continues to face pressure across drug reviews, inspections, compliance, and broader public health policy. For pharmaceutical and biotech companies, changes in FDA leadership always raise questions about regulatory priorities, review timelines, and enforcement focus. While leadership shifts can influence […]
Today, the FDA published a Federal Register (FR) notice (here) announcing a preliminary decision regarding three bulk drug substances that it “has evaluated and is proposing not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide.” The notice further states that the FDA will consider comments submitted to the docket until June 30, 2026 […]
On April 29, 2026, the FDA published a notice in the Federal Register (FR) (posted on the FR prepublication page (here)) announcing the FDA’s intention to withdraw approval of the New Drug Application (NDA) for TAVNEOS (avacopan) capsule, 10 milligrams (mg), held by ChemoCentryx, Inc. and offer the applicant an Opportunity for a Hearing regarding the FDA’s […]
The FDA and industry representatives reported on two more negotiation sessions held on March 4, 2026 and March 6, 2026, the minutes of which are reported in full here and here, respectively. There was some progress—agreements were made on certain topics, and discussions were foreclosed on others—but it looks like we are getting closer to an agreement […]
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Today, the FDA issued a draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection (here).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) […]
As is the case with most negotiation sessions, no agreements were made at this time on the issues discussed. This is a back-and-forth process and the norm as negotiations proceed; the ultimate FDA decision-makers must weigh in on the issues prior to agreement. The full minutes of the meeting can be found here, and some […]
In today’s Federal Notice pre-publication page (here), the FDA is requesting information and comment from industry and the public on whether it’s time to update the series of Scale-Up and Post Approval Changes (SUPAC) guidance documents. The SUPAC documents were issued between 1995 and 1997 (with the exception of SUPAC Manufacturing Equipment Addendum, which was […]
The Association of Accessible Medicines (AAM) continued Day 1 with a discussion of what’s happening on Capitol Hill and how we can be working to position industry priorities with policymakers to make the most positive impact on patient access. The session was conducted as a fireside chat hosted by Mark Ratner, Senior Vice President, Government Affairs, […]
