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Federal Register notice: FDA corrects an 11/21/2022 notice that announced the approval withdrawals of 10 ANDAs from multiple appli...[ Price : $8.95]
Hyman Phelps & McNamara attorneys Mark Tobolowsky and Charles Raver say a recent legislative change on preclinical animal testing ...[ Price : $8.95]
An FDA criminal case involving a Mays Landing, NJ, man who marketed a toxic chemical as a weight-loss drug online has led to a gui...[ Price : $8.95]
FDA places a clinical hold on 4D Molecular Therapeutics 4D-310 drug therapy being studied for treating Fabry Disease Cardiomyopath...[ Price : $8.95]
Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Co...[ Price : $8.95]
CDRHs Accreditation Scheme For Conformity Assessment pilot program transitions to a permanent program based on review efficiencie...[ Price : $8.95]
FDA approves a GlaxoSmithKline NDA for Jesduvroq (daprodustat) tablet that it describes as the first oral treatment for anemia cau...[ Price : $8.95]
Regulatory consulting firm Greenleaf Health brings onboard two former FDA officials former Office of Compliance Don Ashley and fo...