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U.S. Department of Health and Human Services

For Industry

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Prescription Drug User Fee Act (PDUFA) Webinar

In preparation for PDUFA V Reauthorization, FDA developed the following Webinar to better inform stakeholders about the PDUFA program. The presentations below provide a background of the program including PDUFA’s impact on public health, a primer on drug development and FDA’s performance commitments as part of PDUFA, and an overview of FDA’s experience to date in PDUFA IV.

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