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U.S. Department of Health and Human Services

For Industry

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CVM ONADE eSubmitter Program

The Electronic Document Submission and Review (EDSR) System is a collection of tools and systems that make up both the electronic submission and review systems at CVM (i.e., end-to-end electronic submission and review system).

One of those tools, eSubmitter, is an electronic, question-based submission tool that permits the creation and submission of information.  eSubmitter uses data capturing forms (templates) to walk users through the process of compiling a complete and structured submission to FDA.  The templates (available for all submission types, from simple to complex) were developed by CVM subject matter experts.
 

Unsure about using eSubmitter?

As agreed under ADUFA III and beginning October 1, 2014, CVM will replace the end-review amendment (ERA) procedures with shorter review times for qualifying NADA reactivations and INAD resubmissions.  The new procedures apply only to NADA and INAD submissions made through the eSubmitter electronic submission tool (i.e., new procedures are not available for paper submissions).

Click here for more information on CVM's User Fee Programs

 

 

Need Help?

Email us at cvmesubmitter@fda.hhs.gov