FDA releases the form FDA-483 with 14 observations issued following an inspection at the Edmond, OK-based Qualgen outsourcing facility.
FDA clears an iCardio.ai 510(k) for its artificial intelligence software EchoMeasure for interpreting echocardiography.
Jazz Pharmaceuticals plans to file a supplemental NDA next year following positive top-line results from its Phase 3 clinical trial evaluating Zepzelc...
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...
