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CDERs Office of New Drugs says it will convene its Cardiovascular and Renal Drug Advisory Committee to hear an appeal from Ardelyx...[ Price : $8.95]
FDA Review posts the Federal Register notices for the week ending 4/22/2022.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Drug Products, Including Biological Products, That Contain ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding N-acetyl-L-cysteine.[ Price : $8.95]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...