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Register notice: FDA determines that Merck Sharp & Dohmes Noxafil (posaconazole) 100g delayed-release tablets were not withdrawn from sale due...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.
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.
