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San Diego Convention Center

2019年6月23日 (日) 午後 2:30 - 2019年6月27日 (木) 午後 6:00

111 W Harbor Drive, , San Diego, CA 92101 , USA

DIA 2019 Global Annual Meeting

Join thousands of your peers at the life sciences event of the year!

User-Fee Programs Myth Busting: General Financial Principles Explained

Session Chair(s)

Amy  Bertha

Amy Bertha

Executive Director, Regulatory Policy and Science

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)

James  Tyler

Panelist

James Tyler

FDA, United States

Chief Financial Officer, Office of Operations, OC

Andrew  Kish, MS

Panelist

Andrew Kish, MS

FDA, United States

Director, Office of Program and Strategic Analysis, OSP, CDER

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