New FDA guidance lays out clinical trial sponsor safety reporting requirements

The U.S. Food and Drug Administration (FDA) recently published the new draft guidance “Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies,” which provides recommendations to help drug sponsors comply with the expedited safety reporting requirements under an IND or as part of a bioavailability or bioequivalence study that is exempt from IND requirements. The guidance merges content from the 2012 final guidance “Safety Reporting Requirements for INDs and BA/BE Studies” (12/2012) and from the 2015 draft guidance “Safety Assessment for IND Safety Reporting.” Notably, the new draft guidance offers greater flexibility for the requirement that clinical trial sponsors conduct aggregate data analyses, but continues to push for sponsors to unblind safety data in certain cases.