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Federal Register notice: FDA makes available a final guidance entitled E19 A Selective Approach to Safety Data Collection in Speci...[ Price : $8.95]
Contract testing laboratory Valisure relinquishes its regulatory testing ability after a recent FDA inspection raised testing issu...[ Price : $8.95]
FDA updates a January safety communication about the use of Endologix AFX endovascular grafts for treating patients with abdominal...[ Price : $8.95]
FDA issues Verve Therapeutics a formal clinical hold letter that outlines the information required to resolve a hold that was plac...[ Price : $8.95]
FDA confirms the survival rate of Abiomeds Impella RP System that was required to undergo a post-approval study after being approv...[ Price : $8.95]
Pfizer and BioNTech file an application seeking an emergency use authorization for their Omicron BA.4/BA.5-adapted bivalent Covid-...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Statistical Approaches to Establishing Bioequivalence.[ Price : $8.95]
Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), for slowing dise...