CDER director Patrizia Cavazzoni and Office of Therapeutic Biologics and Biosimilars director Sarah Yim say a revised FDA guidance generally does not ...
FDA approves Elanco Animal Healths Zenrelia (ilunocitinib tablets), a once-daily oral JAK inhibitor for controlling itching associated with allergic d...
FDA cites Laboratorios Farmaceuticos Rovi in a four-item Form FDA-484 after inspecting the companys Madrid, Spain manufacturing facility.
FDA clears a Forest Devices 510(k) for the SignalNED Model RE System, a device that uses electroencephalogram technology to assess a patients neurolog...
Federal Register notice: FDA makes available a final guidance entitled Conducting Clinical Trials With Decentralized Elements that provides recommenda...
Braun Medical expands an earlier recall to add lnfusomat Space Infusion System/Large Volume Pump to previous recalled devices due to an erroneous alar...
FDA releases the forms FDA-483 with multiple observations from inspections at Granules India Limited and Gland Pharma, both drug manufacturers in Tela...
Joint comments from three major drug companies about pediatric inflammatory bowel disease drug development question why FDA does not allow broader use...
