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User-Fee Programs Myth Busting: General Financial Principles Explained
Session Chair(s)
Amy Bertha
Executive Director, Regulatory Policy and Innovation
Bayer, United States
With preliminary user-fee reauthorization discussions underway, it is important to refresh on the financial principles behind a user-fee program and hear an update on the PDUFA VI, GDUFA II, and BSUFA II resource management commitments. Don't miss this fantastic educational opportunity to learn more about FDA's financial management.
Learning Objective : Explain how the FDA financials operate beyond the collection of user-fees; Describe and name the general financial principles behind a user-fee program; Describe how FDA utilizes its resources, and discuss the restrictions FDA is under being part of the federal government; Summarize FDA’s progress in implementing the PDUFA VI, GDUFA II, and BSUFA II resource management related commitments.
Speaker(s)
Panelist
James Tyler
FDA, United States
Chief Financial Officer, Office of Operations, OC
Panelist
Andrew Kish, MS
FDA, United States
Director, Office of Program and Strategic Analysis, OSP, CDER
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