Federal Register notice: FDA creates a docket to solicit public comments on a potential modification to its Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that mail-back envelopes for safe disposal option.
Federal Register notice: FDA makes available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.”
FDA grants Bridge to Life a breakthrough device designation for its LifeCradle Heart Preservation Transport System, intended to provide preservation, storage, monitoring, and transportation of donor hearts.