Federal Register notice: FDA makes available a final guidance entitled Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency (...
Federal Register notice: FDA makes available a draft guidance entitled Providing Over-the-Counter Monograph Submissions in Electronic Format.
Two Hyman, Phelps & McNamara attorneys caution that actions providers take in response to an FDA safety communication could be seen by a court as evid...
Covington attorneys say the Justice Department has signaled it remains interested in pursuing False Claims Act cases premised on violations of FDA reg...
FDA approves a Celltrion BLA for Vegzelma (bevacizumab-adcd), a biosimilar to Genentechs Avastin (bevacizumab), for treating six cancer types.
Eisai and Biogen tout the highly significant confirmatory Phase 3 trial results of their investigational Alzheimers drug lecanemab.
Federal Register notice: FDA makes available a final guidance entitled Clinical Decision Support Software.
University of California San Francisco researchers say only one of 15 oncologic drug surrogate analyses conducted by FDA showed a correlation between ...
