FDA to Harmonize Its Regs With HHS Common Rule

The FDA plans to update its regulatory language (21 C.F.R. Part 50) in concert with the governmentwide effort to modernize rules governing the use of human subjects in research, the agency’s good clinical practice director said Oct. 20.

Joanne Less said the Food and Drug Administration’s revisions will be harmonized with the Department of Health and Human Services’ proposed changes to its human subject protection regulations known as the Common Rule (45 C.F.R. Part 46). The FDA wasn’t one of the 16 agencies listed on the notice of proposed rulemaking that went out Sept. ...