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Federal Register notice: FDA extends the comment period on a draft guidance entitled Risk Management Plans to Mitigate the Potenti...[ Price : $8.95]
FDA warns Elite Supplement Center that it is illegally marketing selective androgen receptor modulator products that are legally c...[ Price : $8.95]
FDA accepts for review a Byondis BLA for SYD985 ([vic-] trastuzumab duocarmazine) for use in patients with HER2-positive unresecta...[ Price : $8.95]
FDA grants an emergency use authorization to Watmind USA for its over-the-counter at-home Covid-19 antigen test.[ Price : $8.95]
Federal Register notice: FDA revokes an Emergency Use Authorization issued to Fresenius Kabi USA for its Fresenius Propoven 2% Emu...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of 31 ANDAs from multiple applicants because the products are no longer marketed.[ Price : $8.95]
A New York Magazine investigative report says FDA is partly responsible for delays in getting sufficient monkeypox vaccine doses i...[ Price : $8.95]
FDA grants breakthrough device designation to the Abbott deep brain stimulation system for use in treatment-resistant depression.