Federal Register notice: FDA announces a 9/28 virtual public meeting entitled Reauthorization of the Prescription Drug User Fee Act.
Cardinal Health recalls its Argyle UVC Insertion Tray because it does not include specific instructions for using the safety scalpel N11 contained in ...
Federal Register notice: FDA posts a draft guidance entitled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA....
In comments to FDA, drug companies and industry organizations urge the agency to develop additional and broader guidance on patient-reported outcomes.
Citing a lack of evidence, AstraZenecas Alexion drug unit discontinues its CHAMPION-ALS Phase 3 clinical trial of Ultomiris (ravulizumab) in adults wi...
Cardinal Health recalls three models of its Monoject Saline Flush Prefilled Syringes because their plunger may pull air into the syringe after a healt...
FDA approves the first Covid-19 vaccine Pfizer-BioNTechs vaccine that is now under the trade name Comirnaty.
FDA posts its Prescription Drug User Fee Act VII commitment letter that describes enhancements to the program that will take place beginning 10/1/2022...