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 WEBINAR HIGHLIGHTS •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 FDA GARY GENSINGER Director Regulatory Review Support Staff Office of Business Process Support CDER, FDA.

Deadline for Abstracts:			-

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

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