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U.S. Department of Health and Human Services

For Industry

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PDUFA Annual Reports and Plans

The Prescription Drug User Fee Act (PDUFA) requires FDA to submit two annual reports to the President and the Congress for each fiscal year: 1) a performance report and 2) a financial report. The PDUFA performance reports present FDA’s performance in meeting annual PDUFA review and other goals. The PDUFA financial reports present information on program activities, collections, and spending.

The PDUFA IV Drug Safety Five-Year Plan communicates FDA's strategy for meeting the commitments for enhancing and modernizing the drug safety system within the context of the PDUFA IV program. The PDUFA IV Five-Year Financial Plan presents FDA’s plans for investing the resources expected under PDUFA IV by organization components and PDUFA IV categories.