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FDA Premieres New Plan To Address Opioid Abuse

fda logoToday, Robert M. Califf, M.D., who was nominated to serve as the next commissioner of the U.S. Food and Drug Administration (FDA), released a new, four-tiered comprehensive action plan to address opioid abuse across the country. First, the FDA will improve transparency in the approval process by convening an expert advisory committee before approving new drug applications for any non-abuse-deterrent opioids. Second, the FDA will improve its communication with the medical community, including by enhancing safety labeling and updating the Risk Evaluation and Mitigation Strategy (REMS) program requirements for opioids. Third, the FDA will require drug manufacturers to strengthen post-market analysis of opioids. Lastly, Dr. Califf says the FDA will shift its focus on approving drugs that have potential to help mitigate the epidemic, such as abuse-deterrent formulations, and expanding access to naloxone. Read Dr. Califf’s full post here.

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