On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more
Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more
After several months of uncertainty due to amendments made by the Senate and the dissolution of the National Assembly shortly thereafter, France finally passed a law on February 27, 2025, aiming to reduce risks associated...more
3/20/2025
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