On June 29, 2026, FDA announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative intended to advance U.S. drug manufacturing and improve regulatory predictability for new domestic pharmaceutical manufacturing facilities. The program is designed to give FDA earlier visibility into facility design, [...]

On May 29, 2026, FDA issued its final guidance, “Content of Human Factors Information in Medical Device Marketing Submissions.” The guidance provides a risk-based framework for determining what human factors information should be documented and included in medical device marketing submissions, including 510(k)s, De Novo requests, PMAs, and HDE applications. [...]

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 [...]