FDA holds a Webinar to clarify agency thinking on the distinction between medical device servicing and remanufacturing and to consider cybersecurity i...
Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.
Regeneron Pharmaceuticals and AstraZeneca enter into a collaboration to research, develop and commercialize small molecule compounds directed against ...
King & Spalding attorneys analyze an FDA draft guidance on safety event analysis and reporting in IND and BE/BA studies.
FDA accepts for priority review an Aadi Bioscience NDA for its nanoparticle albumin-bound mTOR inhibitor Fyarro for treating advanced malignant PEComa...
Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2022.
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Reporting 21 CFR Part 803.
Federal Register notice: FDA announces the animal drug user fee rates and payment procedures for fiscal year 2022.