FDA issues new rule for safety reporting

FDA issued a final rule that revises requirements for drug candidate safety reporting. The rule, which the agency hopes will expedite its review of critical safety information, requires some information that trial sponsors previously had not been required to report to FDA be reported within 15 days. The agency said this information includes serious adverse events from bioavailability and bioequivalence studies, serious suspected adverse reactions that occur at a higher-than-expected rate and findings from clinical or epidemiological studies that suggest a significant risk to study participants. ...