In their pre-Christmas government funding bill, US lawmakers were not in a giving mood when it came to bestowing the Food and Drug Administration with a lot of extra authority to ensure drug sponsors conduct sufficiently diverse clinical trials.
Clinical Trial Diversity Action Plans Required Under US Funding Bill
Omnibus legislation requires FDA to issue guidance documents and hold public workshops on clinical trial diversity, but it does not give the agency authority to mandate postmarketing studies if a preapproval trial falls short of demographic diversity goals.
