New FDA guidance lays out clinical trial sponsor safety reporting requirements

Agency offers greater leeway for aggregate data analysis, but continues to promote unblinding of safety data

The U.S. Food and Drug Administration (FDA) recently published the new draft guidance “Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies,” which provides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from the 2012 final guidance “Safety Reporting Requirements for INDs and BA/BE Studies” (12/2012) and from the 2015 draft guidance “Safety Assessment for IND Safety Reporting.” Notably, the new draft guidance offers greater flexibility for the requirement that clinical trial sponsors conduct aggregate data analyses, but continues to push for sponsors to unblind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.

Already registered? Login here.

 

This website is operated by Hogan Lovells Solutions Limited, whose registered office is at 21 Holborn Viaduct, London, United Kingdom, EC1A 2DY. Hogan Lovells Solutions Limited is a wholly-owned subsidiary of Hogan Lovells International LLP but is not itself a law firm. For further details of Hogan Lovells Solutions Limited and the international legal practice that comprises Hogan Lovells International LLP, Hogan Lovells US LLP and their affiliated businesses ("Hogan Lovells"), please see our Legal Notices page. © 2021 Hogan Lovells.

Attorney advertising. Prior results do not guarantee a similar outcome.