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ONADE-ABCT: Deployed a scoped Major Technical Section CMC (I-P-MC) template for ABCT Cell-Based products.
Fixes
ONADE-ABCT: Fixed an issue within the Shipment (I-B-OT) template for ABCT submissions to allow selection of the older common animal until the new target animal approach is adopted across ABCT submissions.
ONADE: Fixed an issue regarding the Early Information (EI) indicator within the NADA meeting requests (N-Z-OM) during the close-out of a review.
ONADE: Updated the certification message displayed during packaging and contained within the administrative coversheet to exactly match the certification text represented within the FDA Form 356v.
ONADE: Added language to request Paragraph IV commitments for RLNAD unexpired patents greater than five years out before allowing a submission to establish a JINAD file (J-A-OT).
ONADE: Updated the J-E-BQ Bioequivalence Protocol submission type based on user feedback.
ONADE: Updated the Bioequivalence Technical Section within the J-P-BQ and A-A-OT submission types based on user feedback.
ONADE: Updated templates for submission types: I/J-B-OT, I/J-O-OT, I/J-S-OT, and I/J-V-OT to use the term "investigational animal(s)" in place of "treated animal(s)" for improved consistency.
ONADE: Adjusted the Core template to hide the question related to submitting an amendment from within the Submission Report when the amendment question is disabled (i.e., for all Original submission types).
ONADE: Adjusted text and order of options within the conditional approval pathway question of the I-P/E-XE templates and added two new questions to the qualifications for expanded conditional approval within the I-G-DE template to better support the needs of the conditional approval program.
ONADE: Created a new template to allow sponsors to submit conditional approval annual renewal submissions.
ONADE: Fixed an issue where the conditional approval pathway question within the Protocol I-E-EF submission type was incorrectly available for ONADE submissions.
OSC-DER: Updated text within the Summary of Labeling Changes sections of various OSC-DER submission types to reflect that Labeling changes requiring a supplemental NADA or ANADA as described under § 514.8 must first be approved through a supplement submitted using the ONADE eSubmitter Program templates.
ONADE: Adjusted the J-P-PE submission type to use the shorter product description form instead of the long form.
Fixes
ONADE: Fixed an issue where the patent type that applies question within the J-P-PE submission type outputs on the submission report when disabled within the data entry.
ONADE: Fixed an issue where the latest Environmental Technical Section template was not being loaded for N/A-A-OT, N/A-E-OT, N/A-C-B1, and N/A-R-B1 submission types.
ONADE: Fixed an issue where the Type of Action options within the Environmental Technical Section were not properly set to ANADA options when loaded from A-A-OT, A-E-OT, A-C-B1, and A-R-B1 submission types.
ONADE: Fixed an issue where the type of labeling being submitted question was not removed within the A-C/R-NL submission types.
ONADE-ABCT: Fixed an issue where the conditional approval pathway question within the Protocol I-E-EF and I-E-CV submission types was incorrectly available for ABCT submissions.
ONADE: Revised section 2.2 of the Notice of Shipment template (I/J-B-OT) by changing "Firm Name" to "Study Site Name" to prevent confusion related to the information being requested.
ONADE: Added language to the Proprietary Name field within the Product Description tab of a submission and the Product Book data entry to clarify that the proprietary name is considered proposed until approved under a new animal drug file or an abbreviated new animal drug file.
Fixes
ONADE: Fixed an issue where the DUNS Number was required entry within section 2.2 of the Notice of Shipment template (I/J-B-OT) after release 1.38. Also, removed the DUNS Number and added back the Telephone and Fax Numbers to section 2.2.
ONADE: Added a new submission type under I-H-OT to allow a sponsor to request written feedback only for a proposed drug development plan under an INAD.
ONADE: Updated sections 1.0, 11.0, 20.1, 20.2, 21.0, 23.0, 26.0, and 29.0 of the Bioequivalence Protocol (J-E-BQ) template.
ONADE: Updated the Environmental Technical Section (I/J-P-NV) template by moving the question related to the type of action the submission is intended to support to section 1.0 where it can be answered for both claims of categorical exclusion and environmental assessment submissions.
ONADE: Fixed an issue within the generated purpose of submission contained within the Administrative Cover Letter of Drug Shipment/Delivery Notice – NCIE (I/J-B-OT) submission types.
ONADE: Updated review division selection for ONADE and ABCT submissions to reflect the removal of HFV-120 "Division of Production Drugs", and the changes to the names for review divisions HFV-110 to "Division of Companion Animal Drugs" and HVF-130 to "Division of Food Animal Drugs".
ONADE: Updated the active ingredient list to reflect the latest changes from the Global Substance Registration System (GSRS).
ONADE: Added text to the Reactivation of an Original ANADA (A-E-OT) submission to reflect that labeling is required even though not listed as one of the selectable technical sections.
All: Updated the listed OMB expiration dates contained within all submission forms across the program areas (i.e., ONADE, OSC, OMUMS).
Fixes
ONADE: Fixed an issue where the question to include sizes being proposed for the generic drug product for an Establish JINAD File (J-A-OT) submission type was no longer available after the product description consolidation. The question now exists within the additional product description section specific to the J-A-OT submission type.
ONADE: Fixed an issue within the establishment/contact imports from the old books to the new books when no address information was available.
All: Fixed an issue within the firm name of the Core templates that limited the firm name to 60 characters when it needs to support up to 75 characters.
