Electronic NDAs: Reviewer, Industry Training Is Focus For CDER Office
Executive Summary
CDER's Office of Information Management will include a focus on training reviewers in the use of electronic submissions
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IND submissions (correction)
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IND submissions (correction)
FDA receives approximately 50,000 INDs each year, all in paper form. "The Pink Sheet" (1Aug. 18, 2003, p. 27) incorrectly reported that the INDs were electronic submissions...
Electronic Adverse Event Filing Could Be Phased In Over Four Years - FDA
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