FDA publishes a draft guidance with updated recommendations for including geriatric information in the labeling for prescription human drugs and biolo...
FDA warns Indias Mayons Pharmaceuticals about CGMP issues in its manufacturing of finished drugs and APIs.
Bill Gates says he no longer has trust in FDA and CDC as independent regulators because of the way they have responded to Trump administration pressur...
FDA sends Mallinckrodt a complete response letter on its NDA for terlipressin and its use in treating adults with hepatorenal syndrome Type 1.
Federal Register notice: FDA requests that stakeholders notify it about their intent to participate in periodic consultation meetings on reauthorizing...
FDA posts a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards.
FDA posts an update on its ongoing pilot to develop a medical device software precertification program that notes FDA is leaning toward a question-bas...
Becton Dickinson CareFusion 303 recalls its Alaris System Infusion Pumps due to damaged inter-unit interface connectors, loose or missing battery scre...