Federal Register notice: FDA postpones a 4/21-planned Pulmonary-Allergy Drugs Advisory Committee meeting that was scheduled to discuss a GlaxoSmithKli...
FDA warns Romanias Global Treat Srl about CGMP violations in its production of finished drugs.
Three stakeholders tell what they like about an FDA draft guidance on biosimilar promotional advertising and labeling.
FDA says it will exercise enforcement discretion for some ophthalmic assessment and monitoring devices during the coronavirus pandemic.
FDA approves a Bristol Myers Squibb and Acceleron Pharma BLA for Reblozyl (luspatercept-aamt) for treating anemia after failing an erythropoiesis stim...
Former FDA commissioner Scott Gottlieb weighs in on hydroxychloroquine for treating coronavirus and what he sees as the better potential of antiviral ...
A new Government Accountability Act report examines 637 NDAs submitted between 2014 to 2018 and found that review times were mainly driven by the char...
Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for the Collection of Qualitative Feedback on...