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FDA issues Takeda Pharmaceutical a four-item Form FDA-483 after inspecting the firms Yamaguchi, Japan manufacturing facility and f...[ Price : $8.95]
Federal Register notice: FDA permanently debars Ivette Maria Portela Martinez from providing services to a person that has an appr...[ Price : $8.95]
Federal Register notice: FDA determines that Mercks Hydrocortone (hydrocortisone sodium phosphate) injection was not withdrawn due...[ Price : $8.95]
A new Government Accountability Office report urges three key strategies for FDAs programs for advancing rare disease products.[ Price : $8.95]
A 2023 FDA inspection of Astellas Pharmas Shizuoka, Japan manufacturing facility leads to a one-item Form FDA-483.[ Price : $8.95]
FDA posts a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products.[ Price : $8.95]
FDA accepts for review an Aldeyra Therapeutics NDA for reproxalap, an investigational topical new drug candidate for treating sign...[ Price : $8.95]
Eyenovia decides to terminate its Phase 3 CHAPERONE study evaluating a drug-device combination of low-dose atropine as a potential...