Novartis recalls one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml due to crystal formation observed in some bottle...
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Federal Register notice: FDA makes available a draft guidance entitled Endogenous Cushings Syndrome: Developing Drugs for Treatment.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 ...
