FDA warns healthcare providers about the possibility that patients who have Medtronics Heartware Ventricular Assist Device System and appear to presen...
CDERs Office of Compliance (OC) says its priorities for 2022 include supporting FDAs Covid-19 response , reducing harm caused by opioid crisis, and im...
FDA updates its Digital Health Policies Web page to include new information from the Covid-19 public health emergency.
Federal Register notice: FDA determines that Abraxis Pharmaceuticals cupric sulfate injection was not withdrawn from sale for reasons of safety or eff...
Federal Register notice: FDA renews the charter of its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two years...
Federal Register notice: FDA makes available a final guidance entitled Providing Submissions in Electronic Format Postmarketing Safety Reports.
The Medical Device Innovation Consortium publishes its framework on external evidence methods for medical devices based on input from FDA and other st...
Simulations Plus completes an FDA-funded project for a model-integrated design for bioequivalence studies in long-acting injectable drugs.