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CVM eSubmitter Application History

Provided below is a history of the 2023 updates to the application software.
Previous CVM eSubmitter Updates

Version 1.63.00 Released 3/15/2023
Enhancements
  1. ONADE: Updated the A-A-OT submission template to allow the FOI file attachment to be optional within section 4.0 "Freedom of Information Summary" for administrative ANADA submissions. 
  2. ONADE: Updated the J-E-BQ submission template to include minor text changes in sections 1.0 "General Information" and 3.0 "Test Article", as well as restructuring of the questions within sections 26.0 "Statistical Methods" and the addition of a new section 26.1 "Analyte and Corresponding Statistical Methods". 
Fixes
  1. ONADE: Fixed an issue where the section list used when amending a J-A-OT submission was either incorrect or blank, resulting in an inability to package due to missing data. 
  2. ONADE: Fixed an issue with the clearing of the Establishment Use Code when importing ADMS information returned by CVM to the sponsor as part of CVM’s submission response after a submission review is completed. 

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Version 1.62.00 Released 2/15/2023
Enhancements

All: Added font scaling to the eSubmitter application to support the variety of screen size/resolution combinations used by industry sponsors. Font scaling can be activated using the following approaches: 

  • Zoom option under the View menu for immediate one time use 
  • Zoom setting under the Layout tab of the Preferences dialog to set the default zoom factor for all time use 
Fixes
  1. ONADE: Fixed an issue where the section list used when amending V-C-AC/MC/MR submissions were blank, resulting in an inability to package due to missing data 
  2. ONADE: Fixed an issue where the I/J-D-OT submission template was not properly loading after the December 2022 release 
  3. ONADE: Fixed issues related to the import of ADMS information returned by CVM to the sponsor as part of CVM's submission response when a submission review is completed:
    • Issue where leading zeros omitted from a document number in the returned ADMS response failed to identify the corresponding document in the sponsor's Product Book
    • Issue where inspection and contact information was being cleared from within the sponsor's ADMS Establishment Book after the ADMS import

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Previous CVM eSubmitter Updates

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