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The RWE Alliance suggests that FDA increase communications with external stakeholders about concrete real-world evidence use cases...[ Price : $8.95]
FDA revises Eli Lillys emergency use authorization for bamlanivimab and etesevimab and Regenerons emergency use authorization for ...[ Price : $8.95]
Federal Register notice: FDA announces recent guidance documents related to the Covid-19 public health emergency.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Collecting and Providing 702(b) Portions of FDA Official Sa...[ Price : $8.95]
Federal Register notice: FDA revokes the Emergency Use Authorizations for five Covid tests because they are no longer marketed, di...[ Price : $8.95]
FDA posts a revised guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhot...[ Price : $8.95]
Medtronic recalls its HawkOne Directional Atherectomy System due to the risk of the guidewire within the catheter moving downward ...[ Price : $8.95]
FDA lifts a partial clinical hold on a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory ...