BioCentury
ARTICLE | Politics, Policy & Law

House user fee reauthorization a platform for FDA reform

Energy & Commerce has a bipartisan deal on enhancing accelerated approval, clinical trials diversity and more

May 5, 2022 12:46 AM UTC

Congress took a big step forward Wednesday toward reauthorizing FDA user fees and setting parameters for FDA reforms.

The House Energy and Commerce Committee has reached bipartisan agreement on user fee reauthorization legislation that would create requirements for clinical trials diversity, strengthen FDA’s power to require confirmatory trials of drugs that receive accelerated approval, and incentivize advanced manufacturing. ...