FDA Review posts the Federal Register notices for the week ending 3/12/2021.
Federal Register notice: FDA corrects a 12/11/2020 notice that announced the withdrawal of of 10 ANDAs from multiple applicants.
Federal Register notice: FDA issues a priority review voucher to Sarepta Therapeutics for a qualifying rare pediatric disease product application Amo...
Federal Register notice: FDA withdraws approval of five Bacitracin for injection ANDAs from multiple holders Akorn, Mylan, Pfizer, XGen Pharmaceutica...
FDA alerts health care providers and laboratory staff about false positive results which can occur with the Roche Molecular Systems cobas SARS-CoV-2 a...
Combat Medical Systems recalls its Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood T...
FDA accepts for review a Marius Pharmaceuticals NDA for Kyzatrex (oral testosterone undecanoate) for primary and secondary male hypogonadism.
AstraZeneca plans to seek an emergency use authorization for its Covid-19 vaccine by early April after determining that it has met FDA data requiremen...