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FDAMA/PDUFA 2 - Can FDA Achieve a Paperless Environment by 2002?
PPT Slide
IT Evolution
Challenges
ERSR Commitments
Technology Approach
Data Transport Models
OIRM - CIO
Information Systems Architecture (ISA) - 1
Information Systems Architecture (ISA) - 2
CDER - Changes Underway
CDER Projects Supporting ERSR
CBER Electronic Cycle
Changes/Challenges
CBER Projects Supporting ERSR
ORA Changes/Challenges
ORA - Electronic Tech Copy
ORA - EES/FACTS
Guidances
Rulemaking
Conclusions
Websites
Download presentation source
Last update: July 13, 2005
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FDA/Center for Drug Evaluation and Research
