Drug Manufacturers’ Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration

Federal regulations require drug manufacturers to report previously unknown side effects and complications of their products to the Food and Drug Administration (FDA) within 15 days of receiving reports of patient injury or death. But a new study by researchers at the University of Minnesota showed that between 2000 and 2014, drug manufacturers didn’t disclose more than 160,000 serious adverse events within the 15-day time frame.

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