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Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding N-acetyl-L-cysteine.[ Price : $8.95]
Federal Register notice: FDA makes available an updated guidance document entitled Emergency Use Authorization for Vaccines to Pre...[ Price : $8.95]
FDA posts a final guidance entitled Refuse to Accept Policy for 510(k)s that outlines the procedures and criteria the agency inten...[ Price : $8.95]
Biogen withdraws a European marketing authorization application for its troubled Alzheimers drug aducanumab.[ Price : $8.95]
FDA accepts for review a Revance Therapeutics BLA resubmission for DaxibotulinumtoxinA for Injection, indicated for treating moder...[ Price : $8.95]
Federal Register notice: FDA withdraws six compliance policy guides because they contain duplicative information or they no longer...[ Price : $8.95]
FDA seeks comments from the pharmaceutical industry on its project to identify and prioritize pharmaceutical quality and chemistry...[ Price : $8.95]
More than 65 scientific experts call on FDA to recommend that Covid-19 vaccine developers assess T-cells in addition to antibodies...