FDA Issues Proposed Rules to Harmonize Regulations on Human Subject Research with Common Rule
- September 30, 2022
The Food and Drug Administration (FDA) issued September 28 two proposed rules aimed at better aligning its regulations on human subject protections (21 C.F.R. pt. 50) and Internal Review Boards (IRBs) (21 C.F.R. pt. 56) with the Department of Health and Human Services (HHS’) regulations know as the Common Rule (45 C.F.R. pt. 46).
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