What is the Prescription Drug User Fee Act: In a Nutshell

Jun 11, 2012 by Clinovo    No Comments    Posted under: Best-Practices

This article was reposted from Pharmaspective, a blog  from Porzio Pharmaceutical Services’ (PPS)

The Prescription Drug User Fee Act (PDUFA) was originally enacted in 1992, and authorizes the federal Food and Drug Administration (FDA) to collect fees from pharmaceutical companies seeking FDA approval of new drugs and biologics. In return for collecting fees, the PDUFA requires the FDA to meet performance benchmarks with the overall intention of making the New Drug Application review process more efficient. Since 1992, user fees collected by the FDA under the PDUFA have permitted the agency to expand its NDA review staff and considerably reduce a product’s review time while still assuring the safety of human drugs. Congress is required to reauthorize the PDUFA every 5 years by September 30th in order to ensure the continuity of the user fee programs.

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