Senator Jeanne Shaheen (D-NH) leads a group of Senators in sending a letter to Danco Laboratories, a manufacturer of mifepristone, urging it to submit...
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...
