FDA accepts for priority review a GSK NDA for gepotidacin, a first-in-class oral antibiotic for treating female adults and adolescents with uncomplica...
FDA commissioner Robert Califf and two colleagues discuss the agencys role in regulating artificial intelligence in biotechnology and healthcare.
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Register notice: FDA determines that Merck Sharp & Dohmes Noxafil (posaconazole) 100g delayed-release tablets were not withdrawn from sale due...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.
