E&C Dems To FDA: Publish Overdue Trial Diversity Guidance

By Jessica Karins / February 22, 2024 at 5:48 PM
Democrats on the House Energy & Commerce Committee are taking FDA to task for missing a deadline to release legally mandated guidance on diversity action plans for pivotal clinical trials, a provision that was included in the Food and Drug Omnibus Reform Act of 2022 (FDORA). The draft guidance was due to be published by Dec. 29 of last year but is not yet available. E&C ranking Democrat Rep. Frank Pallone (NJ) and the ranking Democrats on the health and...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.