FDA’s Regulatory Agenda Sheds Light on Research Rule Changes

Research institutions now have additional clues on the path forward for modernizing regulations to protect research volunteers, even though it’s not clear when they’ll take effect, research attorneys told Bloomberg Law.

The regulatory agenda, a semiannual list of rules federal agencies are pursuing, included three new items from the Food and Drug Administration to update its human subject protection regulations so they line up with an overhaul to another set of human subject protections regulations known as the Common Rule (45 C.F.R. 46). Both rules require studies to meet regulatory standards before scientists can enroll any research volunteers ...