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Federal Register notice: FDA makes available a draft guidance entitled Integrating Randomized Controlled Trials for Drug and Biological Products into ...
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...
