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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:
Created a new Master File Description to be included within VMF submissions that captures details related to the master file, similar to how the Product Description template captures descriptive information for a file/application.
Simplified the Original VMF (V-A-OT) submission type for use to request a new VMF document, while maintaining the VMF Supplement (V-C-OT) to collect the details of the VMF.
Updated the Master File Book to reflect changes included within the new Master File Description template.
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: A/N-A/E-OT, A/N-C/R-NF, A/N-C/R-B1 to support the inclusion of ADMS information.
Updated the Minor Changes and Stability Reports (A/N-B-CA, A/N-F-CA, A-B-AR, A-F-AR) to better support when submission linking is available, and included new validation on the minimum required ADMS Roles and Entities.
Updated the hints for the Entity within the Supply Chain dialog.
ONADE: Updated ANADA submission types (A-E-OT, A-C/R-NL, A-C/R-NF, A-C/R-B1, and J-M-LB) to no longer require the inclusion of RLNAD labeling.
ONADE: Included HFV-130 as a selectable division for A-C/R-NF submission types to support submissions related to GFI #263.
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 type ANADA Original (A-A-OT).
ONADE: Updated the ANADA Original submission type (A-A-OT) for Administrative ANADA’s related to Type A medicated article combinations to support AGDUFA negotiations.
ONADE: Updated the Bioequivalence Major Technical Section submission type (J-P-BQ) to remove the biowaiver letter upload question.
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 ANADA/NADA Minor Changes and Stability Reports (A/N-B-CA, A/N-F-CA, A-B-AR, A-F-AR).
Added support to simplify the inclusion of additional supply chain roles when adding or editing supply chain items for an establishment of an application/file.
ALL: Added support for simultaneous packaging within a shared temporary folder.
Fixes
ONADE: Updated the Route of Administration dictionary to include OTIC (C38192) and to fix a misspelling of INTRASYNOVIAL.
ALL: Fixed the FDA ESG webpage link within the final step of the eSubmitter packaging process.
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
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.
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.
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.
