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DIA 2013 49th Annual Meeting
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Electronic Submissions in PDUFA V
Track : Track 08:Regulatory Affairs and Submissions
Program Code: 252
Date: Tuesday, June 25, 2013
Time: 1:45 PM to 3:15 PM  EST
Location: 206AB
CHAIR :
 Nancy D. Smith, PhD (SCHNON), Independent Consultor, United States
SPEAKER (S):
Mary Ann Slack, (SPKAGY), Deputy Director, Office of Strategic Programs, CDER, FDA, United States
 Mark A. Gray, (SPKAGY), Director, Div of Data Management Services and Solutions, OBI, CDER, FDA, United States
 Stephen E. Wilson, DrPH (SCHAGY), Director, Division of Biometrics III, Office of Translational Science, CDER, FDA, United States
Description
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.

Session Recording
(Code: 252)
DIA 2013 Attendee:
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This session is a part of:
DIA 2013 Live Learning Center
CON3 Comp Access: Tuesday Online Access Package - June 25, 2013
Handout Online
(Code: 252)
DIA 2013 Attendee:
Attendees Login
  
This session is a part of:
DIA 2013 Live Learning Center
CON3 Comp Access: Tuesday Online Access Package - June 25, 2013
Electronic Submissions in PDUFA V