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...
In what is a likely sign of increasing interest on Capitol Hill, the Government Accountability Office releases a new report examining FDA and FTC over...
Federal Register notice: FDA announces an 11/17 Pulmonary-Allergy Drugs Advisory Committee to review a Merck NDA for gefapixant oral tablets.
