FDA Accused of Laxity Over Posting of Clinical Trial Results (1)

Feb. 27, 2023, 9:34 PM UTCUpdated: Feb. 27, 2023, 10:52 PM UTC

The FDA has left as much as $39 billion in uncollected penalties on the table, according to a student activist group that’s calling on the agency to step up its enforcement of a clinical trial transparency law.

The Universities Allied for Essential Medicines North America filed a citizen petition Monday at the Food and Drug Administration that called on the agency to go after more clinical trial sponsors that fail to register their studies and post the results as required by a 2007 law. Those shortcomings are keeping potentially lifesaving data from the public, the petition said.

“It not only ...

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.