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 makes recommendations to prevent damage to wearable medical devices from X-ray imaging, including CT scans.
FDA warns Koreas Outin Futures Corp. about CGMP and misbranding violations at its drug manufacturing facility.
Federal Register notice: FDA determines that Merck Sharp & Dohmes Noxafil (posaconazole) 100g delayed-release tablets were not withdrawn from sale due...
Federal Register notice: FDA issues IntraBio a priority review voucher after determining its recent approval of Aqneursa (levacetylleucine) qualified ...
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.
