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FDA Week - 09/13/2019

FDA Finds Unreported Adverse Events, Urges Compounders To Step Up

By David Roza
September 11, 2019 at 5:22 PM
FDA urged compounders to improve their reporting of adverse events after an agency investigation found that one medical product provider had knowledge of more than 4,000 adverse events associated with compounded products that it had never reported to the agency. FDA stressed the important role adverse event reporting plays in keeping patients safe and announced efforts to finalize an agreement laying out how states should go about identifying and investigating adverse events. The agency has also contracted with the National...


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