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Prescription Drug User Fee Modernization Act (PDUFA)of 2012
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The Prescription Drug User Fee Act (PDUFA) was a law passed by Congress in 1992 which allows the (FDA to collect fees from drug manufacturers to fund the new drug approval process. The FDA is entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.
PDUFA must be reauthorized by Congress every five years as was done in 2002 (PDUFA III), 2007 (PDUFA IV), and 2012 (PDUFA V). Its provisions are negotiated between the FDA and biopharmaceutical industry stakeholders. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

PDUFA V enables more timely patient access to safe and effective new medicines through enhanced scientific communications with sponsors during drug development and throughout the drug review process. It also supporst the development of a framework to facilitate benefit/risk evaluations of new medicines and integrate patient perspectives in the review process, with a particular focus on diseases with considerable unmet needs. Further, the FDA is to increase resources and staffing to validate the use of new scientific tools, such as pharmacogenomics and biomarkers, that can help demonstrate therapeutic benefits more rapidly.
PDUFA promotes a reliable, science-driven regulatory environment that fosters innovation, promotes economic competitiveness and helps maintain high patient confidence in the integrity of medicines.

Related Resources

MichBio Thank You Letter re PDUFA Reauthorization (pdf)
BIO Ref Guide on FDAISA-PDUFA (pdf)
FDA and New Drug Approval Process (pdf)
GenEngNews - FDA Approval Times (pdf)
BIO-PhRMA PDUFA-V Agreement Highlights (pdf)
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