Regulatory Counsel

0910-AI09 201904 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Responsibilities for the Initiation and Conduct of Clinical Investigations

The proposed rule updates FDA’s investigational new drug application (IND) regulations to define and clarify the roles and responsibilities of the various persons engaged in the initiation, conduct, and oversight of clinical investigations subject to IND requirements. The proposed changes should better protect the rights, safety, and welfare of subjects participating in clinical investigations and help ensure the integrity of clinical trial data. The proposed rule should help reduce study misconduct, enhance protection of subjects and ensure the reliability and integrity of clinical trial data (benefits) while requiring additional documenting and reporting for clinical investigators (cost).

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No Fully or Partially Exempt 21 CFR 16 21 CFR 321 21 U.S.C. 355(i) 21 U.S.C. 371(a) No NPRM 04/00/2020 No None No No No No Suzanne Pattee Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-1706 suzanne.pattee@fda.hhs.gov 10903 New Hampshire Avenue, Building 51, Room 3328, Center for Drug Evaluation and Research, Silver Spring MD 20993