FDA leadership has seen significant turnover in May 2026, including the resignation of FDA Commissioner Marty Makary, the appointment of Kyle Diamantas as Acting Commissioner, and a change at the top of CDER with Michael Davis stepping in as acting director after Tracy Beth Hoeg’s departure. This is not a [...]

FDA just gave the industry a very clear signal about AI in a cGMP environment. In an April 2, 2026 Warning Letter to Purolea Cosmetics Lab, FDA included a section on “Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing.” The core issue wasn’t that the firm used AI, it was [...]

On April 16, 2026, FDA’s Center for Devices and Radiological Health (CDRH) issued a Letter to Industry warning manufacturers of CDRH-led combination products about the potential for nitrosamine impurities and outlining what manufacturers should be doing now to identify and manage the risk. Why FDA is raising this now FDA [...]

Combination products don’t usually fail because the science is weak, they fail because teams hit avoidable friction: the wrong lead center, unclear expectations across centers, duplicated information, and quality system gaps that surface late. Two recent FDA Office of Combination Products (OCP) updates give sponsors a clear opportunity to streamline: [...]