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The Pew Charitable Trusts say Congress should give FDA authority to regulate some higher-risk laboratory-developed tests.[ Price : $8.95]
FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend the agency authorize the use of Pfizers Covid-...[ Price : $8.95]
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.