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Electronic Submissions in PDUFA V
Session Chair(s)
Nancy D. Smith, PhD
Adjunct Professor
Temple University, FDA Alumni, United States
CDER will present an update and report on PDUFA performance goals and requirements related to electronic submissions. These include the requirement of electronic submissions and development of clinical and nonclinical terminology standards.
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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