Medical Device Legal News with Sam Bernstein: Episode 11
On 18 July 2025, the European Commission (EC) published the draft guidelines on the implementation of the Foreign Subsidies Regulation (FSR Guidelines)....more
On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more