PDUFA IV IT PLAN

Apr 22, 2008 · The increase in the number of electronic submissions received by the FDA can be directly attributed to the PDUFA III strategy to implement the Electronic Common Document (eCTD) submission format, the implementation of the FDA Electronic Submissions Gateway (ESG), and the implementation of the Electronic Labeling Rule (ELR) and the Physicians Labeling Rule (PLR). ................
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