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  1. FDA eSubmitter

CVM eSubmitter Application History

Provided below is a history of the 2021 updates to the application software.
Previous CVM eSubmitter Updates

Version 1.52.01 Released 2/17/2022
Enhancements

None.

Fixes ONADE: Fixed an issue during the packaging of a CMC supplement submission when no ADMS information is provided. 

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Version 1.52.00 Released 2/15/2022
Enhancements

1.  ONADE: Updated New Animal Drug and Manufacturing (ADMS) capabilities within eSubmitter to better allow the Division of Manufacturing Technology (DMT) to manage the latest information on establishment supply chain data across applications: 

  • Updated submission types N/A-C/R-AI/AP/AS/CI/CP/CS and I/J-P-MC. 
  • Added support for copying/moving supply chain items from one file/application or establishment to another within the ADMS Supply Chain book. 
  • Added support for editing establishment/supply chain information directly within the ADMS Establishment List section of a submission. 

2.  ONADE: Added a new question within ANADA/NADA Original/Reactivation (A/N-A/E-OT), CMC Supplement/Reactivation of Supplement (A/N-C/R-CI/CS/CP/AI/AS/AP), and JINAD/INAD Major Technical section (J/I-P-MC) submissions to identify whether a toxicology assessment is provided. 

Fixes
  1. ONADE: Fixed a textual issue where messages containing section numbers within Request for Meeting (I/N-Z-OM) submission types were no longer correct after a reordering of sections occurred in a previous update. 
  2. ONADE: Fixed a textual issue in Request for Meeting (I/J/N/A/V/G-Z-OM) and Environmental Technical Section submission types to reflect that there are now two Environmental Safety Teams within HFV-160. 

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Version 1.51.00 Released 1/14/2022
Enhancements

ONADE: Updated submission type V-A-OT for VMF Type VIII Import Tolerance submissions to reflect that a U.S. Agent is now required (21 CFR 510.205(d)), effective 1/19/2022, as published in the FEDERAL REGISTER (86 FR 52401) on September 21, 2021. 

Fixes

None.

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Previous CVM eSubmitter Updates

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