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ONADE ABCT: Released new INAD major technical section templates: Claim Validation (I-P-EF), Effectiveness (I-P-EF), and Target Animal Safety (I-P-TS) for use within ABCT submissions.
ONADE ABCT: Included support for identifying Veterinary Innovation Enrollment (VIP) status for INAD major technical section submissions.
1. ONADE: Revised templates in support of ADUFA IV and AGDUFA III User Fee goals:
60 Day CE Submissions: The I-P-NV template was updated to include two new questions to identify if changes to the conditions of use that effect the Environmental Technical section require the resubmission of information and if CVM has offered a 60-day review time.
ADAA Shortened Timeframe: The N-A-OT template was updated to add questions pertaining to the Animal Drug Availability Act (ADAA) Combinations to permit a 60-day timeframe for qualifying submissions.
Tissue Residue Demo: The I-Z-OM template was updated to include a new Meeting scope "Method Demonstration (MD)" and request for the submission number where CVM agreed that the analytical method may proceed to the method trial.
ONADE Pre-Submission Conference: The N-Z-OM and I-Z-OM templates were updated to include expanded questions when the presubmission conference meeting type is selected. This expanded section 6.2 includes individual questions for each technical section to create a complete agenda.
2. ONADE ABCT: Activated templates for use within ABCT submissions.
ONADE: Revised INAD Effectiveness and Target Animal Safety Technical Sections for I-P-EF and I-P-TS submission types in support of industry feedback. (CCR: ESUB-077).
Fixes
ONADE: Fixed an issue related to the validation of attached file names that included embedded periods.
ONADE: Fixed a specific issue within the Chemistry, Manufacturing, and Controls (CMC) technical section when submitting an Original ANADA that is not based on a phased submission approach.
ONADE ABCT: Activated the INAD Major Technical Section (P), Human Food Safety (HF) submission type (I-P-HF) for use within ABCT submissions.
ONADE ABCT: Added new core questions for all ABCT submissions to collect a description of the product and a status on the product use within food-producing species.
ONADE: Incorporated additional textual changes within the Blood Level Bioequivalence Protocol QbR template (J-E-BQ).
Fixes
ONADE ABCT: Removed INAD Environmental Evaluation for Investigational Use (X) templates (i.e., Claim of Categorical Exclusion (CE) and Environmental Assessment (EA)) until updated to meet ABCT requirements.
ONADE: Fixed various issues within the Chemistry, Manufacturing, and Controls (CMC) technical section when submitting an Original ANADA, Reactivation of an Original ANADA, or an INAD/JINAD Major Technical Section submission.
ONADE: Removed the requirement to provide a U.S. Agent/U.S. Employee within General Correspondence (G) and Veterinary Master File (V) submissions for non U.S. firms when one is unavailable.
ONADE: Added a new question to capture Strength and Sizes within the Product Description and Reference Listed Product Description sections of J-A-OT submissions.
ONADE: Incorporated textual changes within the Blood Level Bioequivalence Protocol QbR template (J-E-BQ).
Fixes
ONADE: Replaced 'All Other Information (AOI)' terminology with 'Further Information' within applicable technical section templates.
ONADE: Fixed minor defects within the J-P-HF submission template.
ONADE: Implemented a new and improved approach to attaching files within submissions, as well as managing the overall submission file list. The new approach currently only supports ONADE submissions created within CVM eSubmitter 1.08 or later. See the new File Attachment Quick Guide for details.
OSC: Updated the FDA User Manual links to the CVM Quick Guide.
ONADE: Updated the Request for Meeting (Z) templates with a clarification on our foreign visitor policy. Previously, a foreign visitor was defined as someone that is not a US citizen and does not have a Green Card. Now a foreign visitor is someone that is not a US citizen.
ONADE: Initial template release for the Animal Bioengineering and Cellular Therapies eSubmitter Program.
ONADE: Revised INAD Effectiveness and Target Animal Safety Technical Sections for I-P-EF and I-P-TS submission types with improved organization for data submission (CCR: ESUB-056).
Fixes
ONADE: Fix a defect within Terminate File Request submissions (G-G-TM, I-G-TM, J-G-TM, V-G-TM) when including additional document numbers (CCR: ESUB-060).
Added a section to the "Getting Started" dialog on transmitting a submission to FDA (CCR: ESUB-025).
Added a section to the "Getting Started" dialog on transferring working files from FDA eSubmitter to CVM eSubmitter (CCR: ESUB-024).
Added a link to the CVM eSubmitter website history page (CCR: ESUB-026).
ONADE: Removed question regarding the public announcement of approved applications before publication in the Federal Register from submission types: A-A-OT, A-E-OT, N-A-OT, N-E-OT, N-C-B1, N-R-B1, A-C-B1, A-R-B1 (CCR: ESUB-054).
ONADE: Added new question related to the BL BE Study Design to the BL BE Study QbR Template, J-E-BQ (CCR: ESUB-055).
DER: Updated an important message within the "Alerts and News" tab related to the submission of Drug Experience Reports (DERs).
Fixes
ONADE: Fixed an issue within the Notice of Shipment (B) template where the Total Quantity question within the Product Description screen is not always available (CCR:ESUB-053).
