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FDA posts a final guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Biore...[ Price : $8.95]
Federal Register notice: FDA announces a 2/5 joint meeting of its Drug Safety and Risk Management Advisory Committee and Anestheti...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Expedited Program for Serious Conditions Accelerated Appro...[ Price : $8.95]
GE Healthcare has recalled its Giraffe Omnibed Carestation and Incubator Carestation due to the potential for excessive formaldehy...[ Price : $8.95]
A letter from dozens of patient advocacy groups urges congressional leaders to pass the Creating Hope Reauthorization Act, which w...[ Price : $8.95]
A Texas federal court rules against FDA in an ongoing Freedom of Information Act lawsuit and it must now produce EUA supporting do...[ Price : $8.95]
Reuters says FDA has informed Congress about a 2023 agency inspection at Elon Musks Neuralink that found animal lab issues that wa...[ Price : $8.95]
FDA publishes a draft guidance updating its accelerated approval policies and procedures based on new authority from the 2023 Cons...