Federal Register notice: FDA announces recent guidance documents related to the Covid-19 public health emergency.
Federal Register notice: FDA makes available a draft guidance entitled Collecting and Providing 702(b) Portions of FDA Official Samples Questions and...
Federal Register notice: FDA revokes the Emergency Use Authorizations for five Covid tests because they are no longer marketed, distributed or support...
FDA posts a revised guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Stea...
Medtronic recalls its HawkOne Directional Atherectomy System due to the risk of the guidewire within the catheter moving downward or prolapsing when f...
FDA lifts a partial clinical hold on a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory acute myeloid leukem...
FDA Oncology Center of Excellence director Richard Pazdur suggests changes to the agencys accelerated approval program, such as international harmoniz...
FDA grants Arch Oncology an orphan drug designation for AO-176 and its use in treating relapsed/refractory multiple myeloma.