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Congress Pushes US FDA On Trial Diversity, Accelerated Approval In Approps Report

 
• By Sarah Karlin-Smith

The House Appropriations Committee indicates in fiscal year 2025 appropriations report language that lawmakers will closely monitor the FDA’s implementation of clinical trial diversity action plans. 

colorful ropes joining together
Congress again raises concerns about a lack of alignment among the FDA's drugs and biologics centers in its appropriations report. • Source: Shutterstock

House appropriators continue to amplify lawmaker concerns that the application review practices of US Food and Drug Administration’s drug and biologics centers are inconsistent.

Key Takeaways

  • The appropriations report marks the second time in recent months that Congress has raised concerns about inconsistent rare disease drug evaluation practices in CDER and CBER.

  • The report indicates Congress is closely watching the implementation of new diversity action plan requirements and asks the FDA to help sponsors address recruitment gaps

The

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