FDA clears a BrightHeart 510(k) for its artificial intelligence software for reviewing prenatal ultrasound evaluations of the fetal heart to detect co...
FDA issues Takeda Pharmaceutical a four-item Form FDA-483 after inspecting the firms Yamaguchi, Japan manufacturing facility and finding GMP deficienc...
Federal Register notice: FDA permanently debars Ivette Maria Portela Martinez from providing services to a person that has an approved or pending drug...
Federal Register notice: FDA determines that Mercks Hydrocortone (hydrocortisone sodium phosphate) injection was not withdrawn due to safety or effect...
A new Government Accountability Office report urges three key strategies for FDAs programs for advancing rare disease products.
A 2023 FDA inspection of Astellas Pharmas Shizuoka, Japan manufacturing facility leads to a one-item Form FDA-483.
FDA sends an alert about safety concerns with the use of Getinge/Maquets VasoView HemoPro Endoscopic Vessel Harvesting Systems.
Federal Register notice: FDA seeks comments on an information collection revision entitled Prescription Drug User Fee Program.
