JD Supra

The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...
JD Supra

Model Behavior: FDA and EMA’s Guide to Good AI in Drug Development

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) just issued a joint statement outlining 10 “Guiding Principles” ...