On March 18, 2026, FDA announced a new draft guidance focused on validating New Approach Methodologies (NAMs). These methods are intended to support drug development decisions without relying on traditional animal testing as the default. [...]

FDA recently issued a draft guidance: “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” It’s aiming at drug manufacturing sites regulated by CDER/CBER/CVM and lays out what FDA expects [...]

On February 2, 2026, FDA’s revised 21 CFR Part 820 - now titled the Quality Management System Regulation (QMSR) - became effective. The key change is that FDA now incorporates ISO 13485:2016 by reference as [...]

FDA closed out 2025 - and opened the door to 2026 - with a clear signal to digital health and medical device sponsors: real-world performance of digital technologies is no longer a future consideration, it’s [...]

If you want to know where regulatory expectations are headed, you don’t always need a new guidance document. Sometimes you just need to listen to what regulatory pros keep arguing about. Across recent discussions, three [...]

The U.S. government shutdown has finally ended, and for the FDA, the relief is real. With Congress passing a funding bill covering the agency through September 30 of the next fiscal year, the agency now [...]