Federal Register notice: FDA makes available a final guidance entitled Temporary Policies for Compounding Certain Parenteral Drug Products.
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Register notice: FDA determines that Merck Sharp & Dohmes Noxafil (posaconazole) 100g delayed-release tablets were not withdrawn from sale due...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.
Jazz Pharmaceuticals plans to file a supplemental NDA next year following positive top-line results from its Phase 3 clinical trial evaluating Zepzelc...
