FDA seeks comments from the pharmaceutical industry on its project to identify and prioritize pharmaceutical quality and chemistry and manufacturing a...
More than 65 scientific experts call on FDA to recommend that Covid-19 vaccine developers assess T-cells in addition to antibodies in vaccine trials.
Federal Register notice: FDA creates a docket to solicit public comments on a potential modification to its Opioid Analgesic Risk Evaluation and Mitig...
Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...
FDA approves commercial production at a new Kite CAR T-cell manufacturing facility in Maryland.
FDA says recalls of the Philips Respironics V60, V60 Plus, and V680 Plus ventilators are Class 1.
Federal Register notice: FDA announces modifications to its list of standards the agency recognizes for use in premarket reviews.
FDA grants Bridge to Life a breakthrough device designation for its LifeCradle Heart Preservation Transport System, intended to provide preservation, ...