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Accelerating new drug development

US FDA user fees may have accelerated new drug development but a recent survey suggests difficulties in obtaining volunteers for human clinical trials still slow progress.

John Borchardt(JKBdeinker@aol.com)

HOUSTON The US Food and Drug Administration (FDA) system of user fees has accelerated new drug development, but a recent survey suggests difficulties in obtaining volunteers for human clinical trials still slow progress.

In 1992, the US Congress authorized a five-year program providing the FDA with additional resources to hire more medical and scientific reviewers to conduct pre-market reviews, as well as support staff and field investigators. This Prescription Drug User Fee Act (PDUFA) was intended to accelerate the application review process for human prescription drugs and biological products. The additional resources came from user fees paid by firms requesting an accelerated review of their products. According to Jane Henney, former FDA Commissioner, "There was not then, and never has been, a guarantee of approval," as a result of payment of fees and accelerated review. The increased funding also enabled the FDA to upgrade the agency's information management system.

The...

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