Regulatory Counsel

0910-AH32 201610 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 would update the 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 would better protect the rights, safety, and welfare of subjects and help ensure the integrity of clinical trial data.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 312 21 CFR 16 21 U.S.C. 355(i) 21 U.S.C. 3719(a) No NPRM 05/00/2017 No None No No No No Molly Flannery Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3543 molly.flannery@fda.hhs.gov Center for Drug Evaluation and Research, WO 51, Room 6246, 10903 New Hampshire Avenue, Silver Spring MD 20993