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, ...
FDA publishes a draft guidance explaining its enforcement discretion for dietary supplements containing N-acetyl-L-cysteine.