Adverse drug event 15-day reports for increased frequency would be discontinued under FDA proposed rule.
ADVERSE DRUG EVENT 15-DAY REPORTING FOR INCREASED FREQUENCY WOULD BE REVOKED under an FDA proposed rule published in the Federal Register Oct. 28. FDA regulations currently require sponsors to expedite reporting of serious adverse events already known to be associated with the product when there is an increase in frequency of the reports. The proposed rule would eliminate the requirement; the 15-day reporting requirement would remain in effect for serious, unexpected adverse events.
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