Two Reed Smith attorneys explain how FDA may grant a breakthrough device designation to medical devices that have the potential to address and improve...
Sen. Richard Blumenthal (D-CT), in a second complaint, urges FDA to join the U.S. Department of Justice to thoroughly investigate whether Philips Resp...
Hyman, Phelps & McNamara hires former CDER Office of Immunology and Inflammation director Julie Beitz as a principal drug regulatory expert.
FDA Webview editor Jim Dickinson urges commissioner Robert Califf to begin rulemaking to establish a regulatory definition of substantial equivalence ...
Positive efficacy data prompts Novo Nordisk to stop a kidney outcomes trial (FLOW) that was studying the effects of Ozempic (semaglutide) versus place...
Care Access says an FDA inspection cleared it of good clinical practice violations that had been alleged by Pfizer during its VALOR Lyme disease vacci...
Federal Register notice: FDA determines that certain formulations of Baxter Pharmaceuticals Cytoxan (cyclophosphamide) for injection were not withdraw...
FDA clears a DePuy Synthes 510(k) for the TriLEAP Lower Extremity Anatomic Plating System, a modular, procedure-specific device for use in orthopedic ...
