Federal Register notice: FDA submits to OMB information collection revisions entitled Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Fa...
Mainstream health gadfly Robert K. Kennedy, Jr., says he has been asked by Donald Trump to be heavily involved in choosing people to run FDA and other...
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Federal Register notice: FDA makes available a draft guidance entitled Integrating Randomized Controlled Trials for Drug and Biological Products into ...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...
