Federal Register Proposed rule: FDA is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in falsifying data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. Sponsors must report to the appropriate Center within 45 days. The agency believes the current reporting scheme has caused confusion among sponsors. To view this proposed rule, click here.