Regulatory Counsel

0910-AI09 201910 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 for the Initiation and Conduct of Clinical Investigations

The proposed rule will update FDA’s investigational new drug application (IND) regulations to better 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 are intended to 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 is expected to 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 312 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 360bbb 21 U.S.C. 371 42 U.S.C. 262 No NPRM 09/00/2020 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