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.
CVM ONADE Policy for the Completion of eSubmitter Submissions
Effective November 1, 2016, FDA/CVM/ONADE will expect all eSubmitter submissions to be filled out with complete, accurate and consistent information. The eSubmitter template is considered the authoritative source for all submitted information. All questions that are categorized as a required field (designated with a blue dot in the templates), must contain complete and accurate information that is consistent with any supporting documents attached to the submission. Failure to meet these standards may result in a refuse to review or refuse to file action.
Unsure about using eSubmitter?
As agreed under ADUFA III and beginning October 1, 2014, CVM replaced 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).
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