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ONADE: Added new option for updating patent certifications for various situations under the Patent and Marketing Exclusivity Section of the Administrative ANADA.
ONADE: Updated questions within the AOI section of the Bioequivalence Technical Section to provide more explicit directions for sponsors so that CVM is aware of all information that impacts the evaluation of the Bioequivalence Technical Section.
ONADE: Updated the OMB number date for 0910-0669 within all CVM Core templates (i.e., ONADE, ONADE-ABCT, OSC-DAF).
ONADE: Updated New Animal Drug and Manufacturing (ADMS) capabilities within eSubmitter:
Added support for importing ADMS establishment and supply chain information from Excel spreadsheets
Included new Excel spreadsheet to support ADMS imports
Updated the ADMS Guidebook to reflect new ADMS import capability
ONADE: Updated the Determination of Eligibility (I-G-DE) submission type to improve clarity around questions related to antimicrobial active ingredients and transgenic animals.
ONADE: Updated all submission types requiring environmental technical section information to include additional information when the API is derived from an animal or plant species.&
ALL: Updated the OMB number dates within all CVM Core templates (i.e., ONADE, ONADE-ABCT, OSC-DAF, OSC-DER, OMUMS).
ALL: Updated the application CVM graphic to follow FDA standards.
Fixes
ONADE: Updated all submission types supporting linked documents to limit them to only 20 linked documents per submission to accommodate current limitations in CVM ESS processing.
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:
Added support for specifying a new/updated supply chain operational status based on the latest operational status received back from CVM.
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 the ADMS and Master File Guidebooks.
Updated application hints within the ADMS and Master File dialogs.
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:
Added submission type V-C-AC: A submission that provides CMC updates that may contain minor changes and stability data.
Added submission type V-C-MC: A submission that contains major or moderate CMC changes that are accompanied by a referencing drug product supplement.
Added submission type V-C-MR: A submission that provides a response to an information request or incomplete letter.
Updated submission type V-C-OT: A submission to provide a total update to a Veterinary Master File to support chemistry, manufacturing, and controls (CMC).
Added support for linking supply chain items to VMFs within the Master File Book when previously supply chain items could only be linked to ANADAs, NADAs, INADs, and JINADs within the Product Book.
Added support for importing ADMS updates that are received within submission acknowledgment/correspondence from CVM.
Added an Excel spreadsheet template within the application import subfolder to help sponsors gather ADMS information for inclusion within eSubmitter.
ALL: Fixed an issue within the Submission Report where after it was redesigned it no longer contained numeric references to items contained within multi-file attachment responses or simple table lists.
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.
