0910-AJ13 202510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Responsibilities of Sponsors and Investigators for Clinical Investigations of Human Drugs and Biological Products

FDA is proposing to revise the responsibilities of sponsors and investigators for the conduct of clinical investigations of human drug and biological products in 21 CFR Part 312 subpart D, and to make conforming changes. This rule would update the Agency's requirements for sponsors and investigators to reflect the modern clinical trial ecosystem with a focus on clinical trial quality.  This would improve FDA's ability to ensure the rights, safety, and welfare of trial participants and the reliability of results, while supporting innovation and efficiency in clinical trial conduct.  The proposed updates also would align FDA's requirements with those of our global regulatory counterparts, helping to ensure that sponsors are not incentivized to conduct clinical trials outside of the United States and that studies of drugs and biological products submitted for FDA review are representative of the U.S. population the products are intended to treat.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage No No Not subject to, not significant 21 CFR 54 21 CFR 312 21 CFR 314 21 CFR 601 21 U.S.C. 355 21 U.S.C. 371 21 U.S.C. 374 42 U.S.C. 262 No NPRM 12/00/2026 Undetermined None No No No Emily Gebbia Associate Director 0910 Food and Drug Administration FDA 240 402-0980 emily.gebbia@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 5324, Silver Spring MD 20993