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FDA Withdraw of Three Guidances for eSubmissions

  November 06, 2006  
Drug Information Association, Online
Nov 29 2006

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.
Organized by: Drug Information Association
Invited Speakers: ARMANDO OLIVA,, MD
Deputy Director for Bioinformatics
Office of Critical Path Programs

Regulatory Review Support Staff
Office of Business Process Support

Deadline for Abstracts: -
Registration: http://www.diahome.org/product/12421/06252.pdf
E-mail: dia@diahome.org
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