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The U.S. Food and Drug Administration (FDA) recently published the new draft guidance “Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies,” which provides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from the 2012 final guidance “Safety Reporting Requirements for INDs and BA/BE Studies” (12/2012) and from the 2015 draft guidance “Safety Assessment for IND Safety Reporting.” Notably, the new draft guidance offers greater flexibility for the requirement that clinical trial sponsors conduct aggregate data analyses, but continues to push for sponsors to unblind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

Do you like what you are reading?

Please log-in or register to access Engage and set your preferences

New to Engage?

Create a free account for access to this publication and our vast catalogue of legal updates

Already Registered?

Log-in to continue reading



This website is operated by Hogan Lovells International LLP, whose registered office is at Atlantic House, Holborn Viaduct, London, EC1A 2FG. For further details of Hogan Lovells International LLP 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. © 2022 Hogan Lovells.

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