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Session Chair(s)
Nancy D. Smith, PHD
Adjunct Professor
Temple University, FDA Alumni, United States
Learning Objective : Discuss how the PDUFA V performance goals affect electronic submissions requirements; Explain the steps CDER is taking to implement these goals, and the timeline in which they will occur.
Speaker(s)
eData Standards: Where Are We
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
PDUFA V Electronic Submission Requirements: eCTD Update
Mark A. Gray
FDA, United States
Senior Project Manager, DSB, CBER
CDER Perspective
Steve Wilson, PHD
FDA, United States
Senior Staff Fellow, OB, OTS, CDER
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