Two Axinn attorneys explain a new FDA draft guidance on new clinical investigation exclusivity and ways that some NDA and sNDA applicants may be able ...
Academic researchers call on FDA to continue to modernize its foreign drug inspection program and overcome differences in inspection intensity between...
FDA posts a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations.
FDA commissioner Marty Makary explains how the agency is using AI to modernize tedious tasks performed by humans to make drug reviews more efficient a...
FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend that seasonal influenza vaccines for the 20262027 U.S. season use ...
FDA releases the Form 483 behind a 3/5 Warning Letter to Novo Nordisk that cited serious violations of postmarketing adverse drug experience reporting...
FDA warns Indias Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.
FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equinoxe Reverse Shoulder...
