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CVM eSubmitter Application History

Provided below is a history of the 2024 updates to the application software.
Previous CVM eSubmitter Updates

Version 1.77.00 Released 5/15/2024
Enhancements
  1. ONADE: Added new PZAD Designation Requests submission type under (I-G-OT). 
  2. 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
  1. ONADE: Revised the Shipment template (I/J-B-OT). 
  2. ONADE: Implemented a new Notification of Import submission type under (I/J-G-OT). 
  3. ONADE: Updated the Minor Technical Section template for All Other Information (AOI) (I/J-M-AO) submissions to better organize the AOI attachments. 
  4. 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
  1. ONADE: Removed the Shortened Review Time (SRT) question from the Human Food Safety Protocol (J-P-HF) template. 
  2. 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
  1. 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. 
  2. 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
  1. 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. 
  2. 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). 
  3. 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. 
  4. 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
  1. 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. 
  2. ONADE: Updated the Bioequivalence Protocol (J-E-BQ) template with minor changes to sections 19.0 "Drug Administration" and 26.0 "Statistical Methods". 
  3. 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
  1. ONADE ABCT: Added ABCT specific technical section references within the meeting submission type template (N/I-Z-OM) supporting presubmission conferences. 
  2. 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. 
  3. ONADE: Added support for overriding the ADMS supply chain minimal requirements (i.e., manufacturer/tester drug product/substance) for submission amendments. 
Fixes
  1. 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. 
  2. 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. 

Previous CVM eSubmitter Updates

 
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