FDA issues Takeda Pharmaceutical a four-item Form FDA-483 after inspecting the firms Yamaguchi, Japan manufacturing facility and finding GMP deficienc...
FDA posts a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products.
FDA accepts for review an Aldeyra Therapeutics NDA for reproxalap, an investigational topical new drug candidate for treating signs and symptoms of dr...
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Federal Register notice: FDA determines that Mercks Hydrocortone (hydrocortisone sodium phosphate) injection was not withdrawn due to safety or effect...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.
