Federal Register notice: FDA corrects an 11/21/2022 notice that announced the approval withdrawals of 10 ANDAs from multiple applicants.
Hyman Phelps & McNamara attorneys Mark Tobolowsky and Charles Raver say a recent legislative change on preclinical animal testing may not be as monume...
FDA places a clinical hold on 4D Molecular Therapeutics 4D-310 drug therapy being studied for treating Fabry Disease Cardiomyopathy after the company ...
Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...
CDRHs Accreditation Scheme For Conformity Assessment pilot program transitions to a permanent program based on review efficiencies it has demonstrate...
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 guilty plea on an obstr...
FDA approves a GlaxoSmithKline NDA for Jesduvroq (daprodustat) tablet that it describes as the first oral treatment for anemia caused by chronic kidne...
Regulatory consulting firm Greenleaf Health brings onboard two former FDA officials former Office of Compliance Don Ashley and former FDA Europe Offi...
