FDA Policy/General

CVM Announces its Own eSubmitter Tool

David McFarland

— 1 min read
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CVM 7/24 announced it is issuing its own version of FDA’s eSubmitter tool, to be available next month. In a news release, the Center said the software package will be independent from the FDA eSubmitter program, which is an electronic, question-based submission tool for creating and submitting information in data-capturing templates for all submission types.

CVM said the new tool will provide stakeholders and CVM with the following benefits: 

  • Greater agility and responsiveness to CVM stakeholder feedback on templates and tool bug fixes and enhancements.
  • Singular focus on CVM stakeholder-specific submission needs.
  • Enhanced ability for CVM to meet ADUFA/AGDUFA user fee goals.
  • Further integration of submission technology with other CVM-internal IT systems.

There will be a three-month transition phase during which users will be permitted to select either the FDA eSubmitter program or the CVM-specific version to submit information.

 

 

 

 

 

 

 

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