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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.
