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ONAPE/OGAD: Added multi-file attachment support to the "Reasonable Expectation of Effectiveness Acknowledgement Letter" question of an Original NADA (N-A-OT) conditional approval submission.
Fixes
ONAPE/OGAD: Fixed an issue where the question supporting the inclusion of referenced other documents within an Original NADA (N-A-OT) submission was no longer enabled.
Version 1.90.00
Released 9/15/2025
Enhancements
ONAPE/OGAD: Updated the VMF Supplement (V-C-OT) to include the new CMC templates.
ONAPE/OGAD: Added the new "CMC Technical Section for a Combination of Previously Separately Approved Type A Medicated Articles" template to the new CMC templates.
ONAPE/OGAD: Added the new general VMF Type VII templates V-A-OT and V-C-OT.
ONAPE/OGAD: Removed the IVET VMF templates as the IVET program is no longer active.
Fixes
ONAPE/OGAD: Fixed an issue within the Informal Communications template where you can select DHFS in the Division list but not within Program Support Area selection to be included in the meeting discussion.
Version 1.88.00
Released 7/21/2025
Enhancements
ONAPE/OGAD: Updated the verbiage for products derived from flora/fauna within the environmental I/J-X-CE/EA and I/J-P-NV templates to harmonize the eSubmitter template language with the current language we provide to sponsors.
Fixes
ONAPE/OGAD: Fixed an issue within the HFS section of the N-A-OT template where the attached technical complete letter of an administrative submission is cleared and disabled when saved and reopened, allowing the submission to be packaged without the letter.
Version 1.87.02
Released 5/20/2025
Enhancements
None.
Fixes
OSC-DER: Fixed an issue where the "Promotional or Advertising Materials Submission" template was not loading.
Version 1.87.01
Released 5/19/2025
Enhancements
All: Included an updated file specification quick guide referencing the new individual file size increase to 250 MB.
Fixes
Fixed and issue where the prior OSC-DER core template was not deactivated within the previous release (i.e., 1.87.00).
Version 1.87.00
Released 5/16/2025
Enhancements
ONAPE/OGAD: Adjusted templates in support of the CVM reorganization that split the "Office of New Animal Drug Evaluation (ONADE)" into the "Office of New Animal Product Evaluation (ONAPE)" and the "Office of Generic Animal Drugs (OGAD)".
ONAPE/OGAD: Increased the number of visible rows for multi-file attachment responses from three to ten rows across select questions/templates based on AHI/GADA feedback.
ONAPE/OGAD: Increased the number of characters allowed for total quantity and concentration from 100 to 1000 characters within I-B-OT and I-G-OT submissions.
OSC-DAFI: Adjusted all file attachment questions within OSC Division of Animal Food Ingredients (DAFI) templates to support multi-file selection and all currently accepted file types.
All: Increased the size of individually attached files within submissions from 100 MBs to 250 MBs.
Fixes
ONAPE/OGAD: Fixed an issue where Supplement (C) Administrative Requests (AD) submissions for approved documents (ANADA, NADA) allowed unapproved documents to be included (JINAD, INAD, GC, VMF).
ONAPE/OGAD: Fixed the following issues within CMC templates:
The justification for the solvent question was not being displayed when selecting “Written Justification” within the Residual Solvent Assessment Details section of the 2.3.P Drug Product – Module 2 tab.
The optional/required question statuses were not resetting properly when multiple loads were included within the Sterilization of Component/Equipment by Irradiation sub-sections when switching between where the information supporting the process is located (i.e., Application/File or Both) of the Sterilization Process Validation tab.
The optional/required question statuses were not resetting properly when multiple loads were included within the Terminal Sterilization of Drug Product by Irradiation sub-sections when switching between where the information supporting the process is located (i.e., Application/File or Both) of the Sterilization Process Validation tab.
OSC-DER: Fixed an issue causing sponsor confusion within OSC-DER submissions when including summary of labeling changes.
Version 1.86.00
Released 4/14/2025
Enhancements
ONADE: Improved the performance of accessing product, master file, and ADMS establishment and supply chain book information shared on a network drive by supporting local user indices (see the Alerts/News section from the "Help" menu or introduction screen messages for instructions on setting up the local index support).
All: Performed the periodic maintenance activity of moving inactive templates from the standard templates file to an archive file, thus reducing the size of the active templates file when deploying template updates.
All: Removed the requirement for CVM ESS registration of Responsible Officials/U.S. Agents as no longer necessary based on the new sponsor account management capabilities contained within the new FDA ESG NextGen. Responsible Officials/U.S. Agents will still be required to sign submissions, but they no longer will be validated against CVM ESS.
All: Updated the "Getting Started" dialog for new users to represent the new FDA ESG NextGen capability and removal of CVM ESS registration.
Fixes
None.
Version 1.85.00
Released 2/19/2025
Enhancements
None.
Fixes
ONADE: Fixed issues related to submissions containing CMC Sterilization Process Validation information:
Inability to reference previously entered master files within sections: Sterilization of Components/Equipment by Irradiation, Terminal Sterilization of Drug Product by Irradiation, and Depyrogenation.
Loss of entered data within the run results captured under the Depyrogenation section when reloading the section.
