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FDA posts three new guidances for device makers to use under its Safety and Performance-Based Pathway.[ Price : $8.95]
Federal Register notice: FDA corrects an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Indu...[ Price : $8.95]
Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they notified the agency that the ...[ Price : $8.95]
Federal Register notice: FDA extends the comment period on a draft guidance entitled Electromagnetic Compatibility of Medical Devi...[ Price : $8.95]
Federal Register notice: FDA announces the renewal of its Bone, Reproductive and Urologic Drugs Advisory Committee for an addition...[ Price : $8.95]
FDA grants Lexicon Pharmaceuticals a fast track designation for LX9211 and its use in treating diabetic peripheral neuropathic pai...[ Price : $8.95]
Sanofi and GlaxoSmithKline delay their Covid-19 vaccine program to improve immune response in older adults.[ Price : $8.95]
FDA grants an emergency use authorization for Pfizer-BioNTechs Covid-19 vaccine amid a White House threat for commissioner Stephen...