Bloomberg Law
Dec. 13, 2019, 10:27 AM

Lagging FDA Human Research Rules Draw Cures Law Architects’ Ire

Jeannie Baumann
Jeannie Baumann

Architects of the updated biomedical innovation law have a question for newly-installed FDA head Stephen Hahn: What’s taking so long updating the agency’s protections for research study participants?

The Food and Drug Administration had until Dec. 13 to take steps to make sure its human research study protection rules work in concert with those overseen by the Department of Health and Human Services Office for Human Research Protections, known as the Common Rule. However, it doesn’t appear that the agency will hit that deadline.

So Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.), who are in the early stages of ...

Learn more about Bloomberg Law or Log In to keep reading:

Learn About Bloomberg Law

AI-powered legal analytics, workflow tools and premium legal & business news.

Already a subscriber?

Log in to keep reading or access research tools.