CDER publishes a Manual of Policies and Procedures on the operation of its site selection process for routine inspections.
FDA Webview posts the Federal Register notices published during our 7/3-10 annual Independence Day break.
CDRH says it is transitioning from paper export documents for medical devices to electronic export documents starting 1/2/2024.
FDA approves a labeling update for Novartis Leqvio (inclisiran) to allow earlier use in patients with elevated LDL-C who have an increased risk of hea...
FDA releases a 29-page form FDA-483 with 16 observations from a May inspection at Indias Intas Pharmaceuticals, a manufacturer of the oncology drug ci...
Outset Medical says it will cooperate with FDA in an effort to resolve a 7/5 Warning Letter about its Tablo Hemodialysis System.
Sarepta Therapeutics sells for $102 million its Rare Pediatric Disease Priority Review Voucher that was awarded last month.
FDA issues Hemogenyx Pharmaceuticals a clinical hold on an IND for the companys chimeric antigen receptor T-cells therapy for treating acute myeloid l...
