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FDA warns Medtronic about Quality System and Medical Device Reporting violations at its Northridge, CA, manufacturing facility.[ Price : $8.95]
FDA issues a draft guidance on assessing the credibility of computational modeling and simulation in medical device submissions.[ Price : $8.95]
FDA issues an emergency use authorization for Mercks molnupiravir to treat mild-to-moderate Covid-19 in some adults.[ Price : $8.95]
Padagis recalls three lots of 12 g spray bottles of nitroglycerin lingual spray labeled for Perrigo due to the potential for a def...[ Price : $8.95]
FDA grants an emergency use authorization for Pfizers Paxlovid, the first oral treatment for some Covid-19 cases.[ Price : $8.95]
FDA tentatively approves Amphastars vasopressin injection, a generic form of Pars Vasostrict.[ Price : $8.95]
FDA sets a 6/22 PDUFA action date for an Amylyx NDA for its Alzheimers investigational drug.[ Price : $8.95]
FDA clears Bioventus neXus bone scalpel handpiece.