Bloomberg Law
Aug. 23, 2021, 8:37 PM

FDA, Brand-Name Drug Industry Agree on Next Round of User Fees

Jeannie Baumann
Jeannie Baumann

The pharmaceutical industry and the FDA reached an agreement on the next round of user fees, teeing up for Congress must-pass legislation to renew the fees that help fund the agency.

The commitment letter released Monday marks a critical milestone in setting up fees the industry will pay the Food and Drug Administration for the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII). The letter also describes the performance goals and procedures of the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for 2023-2027.

User fees paid by ...