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ONADE: Fixed an issue related to the disabling of the labeling sections within CI/CS/CP supplement and reactivation of supplement submissions when switching between activating labeling changes to deactivating labeling changes.
Version 1.83.00
Released 11/18/2024
Enhancements
ONADE: Updated the target animal exception text from "Except" to "Not for use in" within the product description section to reflect working policy.
All: Incorporated speed improvements to submission packaging, as well as updated the packaging quick guide to provide guidance on how to improve packaging performance based on user working folder locations.
ONADE DABCT: Separated DABCT Type VII Supplement submissions into the following distinct classification codes: Periodic Report (AC), Shipping Information (AC), New Study Information (MC), New Facility or Study Site (MC), Enforcement Discretion Request (MR), Other Info, Reports, or Requests (OT), Donor Eligibility (OT).
ONADE: Updated the wording of the attachment question within section 4.1 "FOI Summary" of the Original ANADA submission type (A-A-OT) to "Attach the corrected Freedom of Information Summary".
ONADE: Added a question to capture the referenced GC submission number within section 3.0 "Supporting Information" of the Establish JINAD File submission type (J-A-OT).
Fixes
ONADE: Fixed an issue related to referenced master files within the ADMS import from CVM.
ONADE: Fixed an issue where section 3.3.5 "Paragraph 4" of the Original ANADA submission type (A-A-OT) was missing the appropriate patent information sub-sections.
Version 1.82.00
Released 10/15/2024
Enhancements
ONADE: Updated the ANADA Original and Reactivation templates (A-A/E-OT) to include the new CMC templates.
Fixes
ONADE: Fixed defects within the new CMC templates (i.e., drug product, drug substance, and sterilization process validation).
Version 1.81.00
Released 9/27/2024
Enhancements
ONADE: Completely revised the Chemistry, Manufacturing, and Controls - Major Technical Section submission (i.e., I/J-P-MC) to support complete and component-based approaches.
Fixes
ONADE: Fixed an issue where the TSC letter attachment was not retained for an N-C-B1 submission after the submission was saved and reopened.
Version 1.80.00
Released 8/15/2024
Enhancements
None.
Fixes
ONADE: Fixed an issue within the Microbial Food Safety section of a Request for Meeting submission type designated as a presubmission conference.
ONADE: Fixed an issue where a non-US sponsor without a US agent or US based employee could submit without a designated responsible official provided.
Version 1.79.00
Released 7/15/2024
Enhancements
None.
Fixes
ONADE: Fixed an issue where the referenced "H" submission number within an INAD Protocol submission (i.e., I-E-EF/TS/MC/NV/HF/XE) was not being captured during CVM submission receipt processing.
Version 1.78.00
Released 6/21/2024
Enhancements
ONADE: Updated the list ordering and hint text for VMF submission type classification codes.
ONADE/DABCT: Updated section 2.0 "Comments" of the DABCT General Correspondence (V-C-OT) template to support multiple file attachments.
ONADE: Updated the template language for collecting JINAD filing fees for the first Chemical, Manufacturing, and Controls; and Bioequivalence technical section submission types.
Fixes
ONADE: Fixed an issue where the ADMS tab was improperly loaded when selecting ADAA Combination for an N-A-OT submission type.
ONADE: Fixed an issue where two questions were being improperly cleared upon reopening of an N-G-OT submission type.
Version 1.77.00
Released 5/15/2024
Enhancements
ONADE: Added new PZAD Designation Requests submission type under (I-G-OT).
ONADE/DABCT: Added alternate digital signing capabilities to DABCT and ONADE Communications submissions.
Fixes
ONADE: Fixed issue where HFV-160 was not available as a review division for I/N-G-OT submissions.
Version 1.76.00
Released 4/15/2024
Enhancements
ONADE: Revised the Shipment template (I/J-B-OT).
ONADE: Implemented a new Notification of Import submission type under (I/J-G-OT).
ONADE: Updated the Minor Technical Section template for All Other Information (AOI) (I/J-M-AO) submissions to better organize the AOI attachments.
ONADE/DABCT: Updated the General Correspondence Administrative template (I/N-G-AD) to set the review division to HFV-180 for U.S. Agent changes.
Fixes
ONADE: Removed the Shortened Review Time (SRT) question from the Human Food Safety Protocol (J-P-HF) template.
ONADE: Adjusted the Sponsor ADMS import from CVM to only import the first document when linked documents are included.
Version 1.75.01
Released 3/22/2024
Enhancements
None.
Fixes
ONADE: Fixed a defect within the Informal Communication submission type that prevented packaging and required elements of the Responsible Official section that should be optional.
ONADE: Fixed an issue where an ERL Communication submission type was being received as a new "Z" submission instead of as an amendment to an existing "Z" submission.
Version 1.75.00
Released 3/15/2024
Enhancements
ONADE: Added a new submission type under the ONADE Communication core template to support an informal communications process for sponsors to submit questions via eSubmitter rather email or telephone.
ONADE: Added new questions to improve clarity on the types of information to be included within an I-G-OT submission (i.e., upcoming submissions or milestone reports; chemistry, manufacturing, and controls information; or other information).
ONADE: Increased the number of visual rows within several multi-file attachment questions across various submission types (I-P-NV/EF/TS/HF, I-M-AO, I-A-OT, I/N-G-OT) from three to ten rows, per sponsor recommendations.
ONADE: Adjusted the AOI section of the N-C-B1 submission type to accept multiple files instead of a single file previously allowed.
Fixes
ONADE: Fixed a defect preventing ADUFA/AGDUFA user fee waiver submissions (G-C/R) from being created after eSubmitter release 1.74.
Version 1.74.00
Released 2/15/2024
Enhancements
ONADE: Added support for overriding the ADMS supply chain minimal requirements (i.e., manufacturer/tester drug product/substance) for specific situations involving drug product intermediates in submission types: A/N-C-B1, A/N-B/F-CA, A-B/F-AR.
ONADE: Updated the Bioequivalence Protocol (J-E-BQ) template with minor changes to sections 19.0 "Drug Administration" and 26.0 "Statistical Methods".
ONADE/ABCT: Added support to permit a Z submission to be the first submission type that establishes a GC document.
Fixes
None.
Version 1.73.00
Released 1/19/2024
Enhancements
ONADE ABCT: Added ABCT specific technical section references within the meeting submission type template (N/I-Z-OM) supporting presubmission conferences.
ONADE: Added support for overriding the ADMS supply chain minimal requirements (i.e., manufacturer/tester drug product/substance) for specific situations involving drug product intermediates.
ONADE: Added support for overriding the ADMS supply chain minimal requirements (i.e., manufacturer/tester drug product/substance) for submission amendments.
Fixes
All: Fixed an issue where pasted HTML responses (e.g., tables) are truncated on the left edge when viewed from the Submission Report due to the tables being outside the margins of the source document.
ONADE: Fixed an issue within the meeting submission type template (N/I-Z-OM) supporting presubmission conferences where requests for first pre-submission conference (PSC) meetings were not being redirected to division HFV-180.
