Federal Register notice: FDA establishes the prescription drug user fee rates for fiscal year 2020.
FDA grants B. Braun Interventional Systems a breakthrough device designation for the SeQuent Please ReX drug-coated percutaneous transluminal coronary...
FDA and the European Medicines Agency publish the report on a 2018 joint workshop on quality development in drug early access approaches.
Federal Register notice: FDA seeks comments on an information collection extension for medical device GMP regulation.
Federal Register notice: FDA seeks comments on an information collection extension for Unique Device Identification (UDI) System 21 CFR Parts 16, 801...
FDA publishes a draft guidance to assist drug sponsors planning to conduct clinical studies in neonates.
FDA makes available a draft guidance entitled E8(R1) General Considerations for Clinical Studies.
FDA and HHS issue a plan with two potential paths for importing certain drugs from foreign countries, but Canadians object.