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Federal Register notice: FDA sends to OMB an information collection revision entitled Registration of Producers of Drugs and Listi...[ Price : $8.95]
Eyenovia receives a complete response letter on its NDA for MydCombi (tropicamide and phenylephrine), indicated for in-office pupi...[ Price : $8.95]
FDA grants Alkermes a fast track designation for nemvaleukin alfa, an engineered interleukin-2 variant immunotherapy for use in co...[ Price : $8.95]
CDERs Office of New Drugs says an advisory committee meeting will be convened to review an Avenue Therapeutics dispute resolution ...[ Price : $8.95]
Federal Register notice: FDA announces a 12/10 meeting of the Medical Devices Advisory Committees Neurological Devices Panel that ...[ Price : $8.95]
FDA posts a six-observation Form FDA-483 after inspecting a Biocon drug substance manufacturing facility in Malaysia.[ Price : $8.95]
CDRH creates a patient resource Web page to provide information about endometrial ablation for heavy menstrual bleeding.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Data Standards for Drug and Biological Product Submissions ...