[ Price : $8.95]
FDA grants B. Braun Interventional Systems a breakthrough device designation for the SeQuent Please ReX drug-coated percutaneous t...[ Price : $8.95]
FDA and the European Medicines Agency publish the report on a 2018 joint workshop on quality development in drug early access appr...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for medical device GMP regulation.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for Unique Device Identification (UDI) System ...[ Price : $8.95]
FDA publishes a draft guidance to assist drug sponsors planning to conduct clinical studies in neonates.[ Price : $8.95]
FDA makes available a draft guidance entitled E8(R1) General Considerations for Clinical Studies.[ Price : $8.95]
FDA and HHS issue a plan with two potential paths for importing certain drugs from foreign countries, but Canadians object.[ Price : $8.95]
FDA releases the FDA-483 with seven inspection observations issued following an agency inspection at the Cipla Virgonagar, India, ...