CDER director Patrizia Cavazzoni says the Center worked with CBER to launch in 2023 the START program, providing selected participants enhanced commun...
FDA posts a consumer-focused explanation of how CDER determines and manages drug shortages.
CDRH pilots medical device trial participation snapshots to provide key information about clinical trials that supported their approval.
FDA gives the green light to Iota Biosciences for an early feasibility study of its investigational implantable device in underactive bladder patients...
Federal Register notice: FDA makes available a final guidance entitled Endosseous Dental Implants and Endosseous Dental Implant Abutments Performance...
FDA approves a Bausch + Lomb PMA for its EnVista Envy intraocular lens for use in cataract surgery.
GSK says it will submit a BLA based on positive data from two Phase 3 trials evaluating depemokimab in chronic rhinosinusitis with nasal polyps.
FDA clears a Heidelberg Engineering 510(k) for its Spectralis Flex Module for imaging the posterior segment of pediatric and adult patients in a supin...
