FDA provides further clarification about a safety alert issued earlier this year that recommended against the use of certain surgical N95 respirators ...
Federal Register notice: FDA makes available a draft guidance entitled Endogenous Cushings Syndrome: Developing Drugs for Treatment.
Federal Register notice: FDA posts a final guidance entitled Use of International Standard ISO 109931, Biological Evaluation of Medical Devices Part ...
Federal Register notice: FDA makes available a final guidance entitled Application of Human Factors Engineering (HFE) Principles for Combination Produ...
U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) reintroduce their bipartisan FDA Review of Efficacy EERW Double-Blinds (FREED) of Opioids Act.
The House Energy and Commerce Committee announces a 9/14 legislative hearing to discuss legislative proposals on preventing generic drug shortages.
FDA posts a guidance entitled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and ...
FDA requests updated chemistry, manufacturing and controls information on Genentechs subcutaneous formulation of lung cancer drug Tecentriq (atezolizu...
