Federal Register notice: FDA amends a 12/12/2023 notice requesting nominations for voting members to serve on CDERs Genetic Metabolic Diseases Advisor...
Gilead Sciences pauses enrollment globally in its magrolimab solid tumor studies and FDA subsequently requests (XXX TENSE XXX) a partial clinical hold...
CDRH Office of Product Evaluation and Quality (OPEQ) director William Maisel announces he will retire this spring.
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances on the design of bioequivalence studies...
FDA grants Diamyd Medical a fast-track designation for Diamyd (rhGAD65/alum) and its use in improving glycemic control in some diabetes patients.
FDA clears a Merit Medical Systems 510(k) for the SCOUT MD Surgical Guidance System for use in implanting surgical reflectors in abnormal breast tissu...
FDA makes available a final guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.
Federal Register notice: FDA announces that its Office of Digital Transformation has modified its organizational structure.
