FDA Withdraw of Three Guidances for eSubmissions

Venue: Online

Location: Online, Pennsylvania, United States

Event Date/Time: Nov 29, 2006 End Date/Time: Nov 29, 2006
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Learn Why the FDA Withdrew Three Guidances for eSubmissions On September 29, 2006, the FDA’s Center for Drug Evaluation and Research announced the withdrawal of three guidances for eSubmissions. These Guidances covered:
•New Drug Applications (NDAs)
•Abbreviated New Drug Applications (ANDAs)
•Annual Reports for NDAs and ANDAs
•Why previous guidances are no longer consistent with more recent guidances
•Why they no longer reflect the Center’s preferred format for receiving electronic submissions
•Why the eCTD format is now preferred by the FDA.