Provided below is a history of all updates to the application software.
All: To maintain compliance with FDA standards, eSubmitter has now incorporated the Geopolitical Entities, Names, and Codes (GENC) Standard for countries and subdivisions. For more information, see the eSubmitter "Alerts and News" section.
1. ONADE: Updated the Food Use Authorization templates for submission types (I/J-D/O-OT) to include the following changes:
Submission type options related to dosage form, route of administration, and target animal are now derived from the product description section.
Prevent submission from packaging when sponsor is unable to certify that treated animals will remain under investigational conditions and under supervision for the established drug investigational withdrawal period.
Updated hint related to waiver request.
Updated language to align with P&P 1243.4040 and investigational food-use authorization letters.
2. ONADE-ABCT: Added the three Expanded Conditional Approval (XCA) submissions types (I-G-DE, I-P-XE, I-E-XE).
ONADE: Provided access to the Product Book without requiring a submission to be opened.
ONADE: Revised the General Correspondence - Termination submission types (J/I/G-G-TM) to improve clarity regarding the certification responses.
ONADE and OSC: Fixed an issue where an edit dialog was accessible from the selected item of a multi-file attachment list that is no longer needed within templates supporting the improved file attachment approach.
ONADE: Fixed an issue where the submission correspondence date was missing from within the submission package when using the new digital signature approach during packaging.
ONADE: Added a new option that allows the Responsible Official to digitally sign the Administrative Cover Sheet externally from eSubmitter and have it attached during the submission packaging step. Using this new option, the Responsible Official does not need to be present during the submission packaging process. The pre-existing option of digitally signing a submission during the packaging step is also still available.
All: Added a 100-character limit constraint to the length of attached file names within eSubmitter.
ONADE-ABCT: Updated section 1.0 of the Human Food Safety Technical Section (I-P-HF) to support multiple components (i.e., Toxicology, Residue Chemistry, Microbial Food Safety) within a single submission.
OSC-DER: Updated the DER Core template to support the revised eSubmitter file attachment approach that ensures unique file names and prevents special characters within file names.
ONADE: Updated the Notice of Shipment (B) submission type (I/J-B-OT) to include revised acknowledgment text in section 3.0, as well as adjusted the target animal question in section 1.2 to derive its options from the product description section.
ONADE: Revised the message when selecting a VMF file type within section 6.0 Submission Type Code to include Import Tolerance.
All: Fixed the HTML tagging issue within the output of the eSubmitter Missing Data/Validation Issues report.
ONADE: Fixed an issue within the Notice of Shipment (B) submission type (I/J-B-OT) that resulted in some sections being incorrectly enabled when reopening a submission file.
ONADE: Fixed an issue that incorrectly disabled section 2.6 Labeling of a B1 Supplement (N-C-B1) submission.
ONADE: Fixed an issue where the Determination of Eligibility (I-G-DE) template did not include the revised product description section.
ONADE/ONADE-ABCT: Added, updated, and reorganized various options within sections 1.0, 2.0 and 4.0 of the Human Food Safety Technical Section submission type (I-P-HF).
ONADE: Revised questions related to patents in section 2.1 "Additional Reference Listed Product Description" of the submission type (J-A-OT) to reflect patents expired and unexpired in the Green Book at FDA.
ONADE: Fixed an issue where the purpose of submission selection was not retained after closing and reopening General Correspondence/Supplement Administrative Request submission types for ANADA/NADA document types (A/N-G/C-AD).
ONADE: Fixed the amendment section options across various submission types to reflect the reorganization that moved the production description before the submission details.
ONADE: Fixed the submission type to establish a new JINAD file (J-A-OT) to remove redundant questions that remained after the product description was moved to before the submission details.
ONADE: Fixed an issue that prevented packaging of a Notice of Shipment (B) submission type (I/J-B-OT).
ONADE ABCT: Removed the question supporting a VIP enrollment request when creating I-A-OT and V-A-OT submissions specific to only Gene Therapy (GT) products.
ONADE: Provided an option for sponsors to attach a letter from CVM granting a biowaiver within J-P-BQ and A-A-OT submissions, thereby removing the requirement to provide blood level bioequivalence study information within the submission.
ONADE: Added support for attaching multiple files to the Final Study Report (FSR) question within J-P-BQ submissions.
ONADE: Fixed an issue within section 2.3 "Test and Control Article Characterization" of I-P-EF and I-P-TS submissions that resulted in the potential loss of information when multiple study types were included.
ONADE: Fixed an issue with the total quantity and concentration shipped question within section 2.0 "Shipment or Receipt Information" of an I-B-OT submission that was identified after the new product description deployment.
ONADE: Corrected a defect within the Notice of Shipment template (I-B-OT) where the question requesting information on the total quantity and concentration of drugs shipped was missing from the template after the new product description was deployed.
ONADE: Corrected a defect within the Original VMF template for CMC (V-A-OT) where the product description template was inadvertently loaded when it shouldn’t have been after the new product description was deployed.
ONADE: Included new Product Book/Product Description capabilities to improve how product description information is collected for ONADE submissions and how the information is managed by industry stakeholders.
ONADE: Adjusted the N/I-Z-OM template for Pre-Submission Conference requests to help the primary reviewer determine when the Division of Human Food Safety (HFV-150) should be consulted for the purpose of a Human User Safety evaluation.
OSC-DER: Updated hyperlinks within OSC-DER templates to reflect recent changes in URL addresses within FDA.
ONADE: Corrected a defect within the Notice of Shipment template (I-B-OT) to no longer require sections for Notice of Claimed Investigational Exemption (NCIE), imports, and shipment type information for minor species reports that are submitted in batched shipment notices.
ONADE: Updated language within section 6.2 "Pre-submission Conference" of the Request for Meeting submission types (I-Z-OM and N-Z-OM), so sponsors will have clearer language to communicate to CVM the desired scope of the pre-submission conference meeting.
ONADE: Removed the Early Information (EI) question from the INAD Request for Meeting submission type (I-Z-OM), since ONADE will no longer be accepting meeting submissions for EI under the INAD document type.
ONADE: Added a warning message to the creation of General Correspondence (G) document types to explain that these are typically used for submitting pre-INAD information, waiver requests, and other less common type of submissions; and if the sponsor needs to submit a general correspondence submission for an existing file or application (i.e., NADA, INAD, ANADA, JINAD, VMF), they should select the appropriate document type and General Correspondence as the submission type.
ONADE: Removed the reference to "Guidance for Industry 42" (GFI 42: Animal Drug Manufacturing Guidelines) from submissions containing the major technical section for Chemistry, Manufacturing and Controls (CMC) until further notice.
ONADE: Incorporated new updates into the Bioequivalence Protocol (J-E-BQ) template.
ONADE: Corrected a defect within the core template where the submission classification codes (SCC) were not properly resetting when changing the user fee type of a user fee waiver request submission.
ONADE: Included a new announcement within the "Alerts and News" section of the eSubmitter introductory screen regarding new waiver submission types and added new message text and updated hints within the Submission Type Selection section to aid in selecting the correct waiver type.
ONADE: Corrected a defect in the Paragraph III Certification for the A-A-OT and A-E-OT templates under Section 3.0 Patent Certification and Marketing Exclusivity.
ONADE: Released a new template to support the electronic receipt of submissions for the determination of eligibility (I-G-DE).
ONADE: Included revisions to the Blood Level Bioequivalence Major Technical Section QbR template (J-P-BQ), as well as now supporting all the J-P-BQ QbR capabilities within an Original ANADA submission (A-A-OT).
ONADE: Fixed an issue where the CMC Major Technical Section tab was not properly unloaded within an A-A-OT submission when switching to an Administrative ANADA.
Fixed an issue where HFV-170 could not be selected as the primary review division for ANADA B1 supplements and reactivations (A-C-B1, A-R-B1).
ONADE ABCT: Added HFV-180 as a review division option within the following ABCT submission types (I/G/N/V)-G-AD, (I/G/N/V)-G-OT, (I/G/N/V)-G-TM, (I/G/N)-Z-OM, and (I/G/N)-Y-OM.
ONADE ABCT: Included "Recombinant DNA Technology" section within ABCT I-X-(CE/EA) submission types when only IGA is selected as a product category.
ONADE: Updated the Electronic Submission System (ESS) - Acceptance and Rejection Messages document to include corrective actions for common submission issues. A reference to the revised document is now available within the eSubmitter "Alerts and News" and "Frequently Asked Questions".
ONADE: Adjusted the Original ANADA and NADA submission types to automatically require the Environmental Technical Section.
ONADE: Removed redundant questions from with (I/J)-P-NV submission types.
ONADE ABCT: Added a new "Other Information, Reports, or Requests" option to the information contained within the submission question of the ABCT Type VII VMF Supplement submission type (V-C-OT).
ONADE: Removed the labeling type submitted question with the response options of Final Printed Labeling (FPL), Facsimile Labeling, or Combination of FPL and Facsimile Labeling from several submission types where it is no longer relevant (i.e., A-C-B1, A-R-B1, A-A-OT, A-E-OT, A-C-NL, N-A-OT, N-E-OT, N-R-B1, N-R-NK, N-C-B1, N-C-NL).
ONADE: Added a popup warning message to CMC submission types where document linking was recently included, to remind sponsors that by providing additional documents they are creating linked submissions, which will duplicate all the information provided in the current submission to all the additional documents/applications referenced.
ONADE: Added a new popup message within the ONADE/ABCT core templates to provide additional clarity on when it is appropriate to select "Yes" to the amendment option to amend a submission currently pending and under review by CVM.
ONADE: Revised the formulation questions within the Test and Control Article Characterization section of the INAD Effectiveness (I-P-EF) and Target Animal Safety (I-P-TS) templates.
ONADE: Fixed an issue within the Blood Level Bioequivalence Major Technical Section template (J-P-BQ) that resulted in missing data issues when created using the "Save-As" feature from a submission based on the older template structure.
ONADE: Release of submission template for import tolerance (VMF) files.
ONADE: Fixed an issue where file attachments removed from the submission file list were not always removed from associated question responses (i.e., the issue was specific to I-P-EF and I-P-TS submission types).
ONADE ABCT: Added a new question within the ABCT I-A-OT and V-A-OT submission types to allow sponsors to request enrollment in the Veterinary Innovation Program (VIP).
ONADE: Fixed an issue within CMC Technical Section submissions where section 2.3.P.4.d "Excipient Manufacturer" was incorrectly activated when selecting "Yes" to "Does the product contain excipients?" when it should only have been activated when selecting "Yes" to "Are any novel excipients being utilized?".
ONADE: Fixed an issue within A-E-OT submissions where section 3.3.7 "Marketing Exclusivity" was not being activated when selecting "Patent Certification and Marketing Exclusivity" from within section 3.0 "Technical Section".
ONADE: Fixed an issue where the Responsible Official phone number was incorrectly formatted within the Submission Report.
ONADE ABCT: Fixed issues within the review division selection list for several ABCT INAD and VMF submission types.
ONADE: Updated all "Z" meeting templates (I-Z-OM, N-Z-OM, A-Z-OM, J-Z-OM, G-Z-OM, and V-Z-OM) to enable contact/address book support when identifying contacts to include as Firm Participants in Section 4.0.
All: Added hyperlink support to email addresses within the eSubmitter Submission report to auto-generate a pre-addressed email using the default email client application.
ONADE: Removed the CBE-30 question from CMC submission types where it was incorrectly made available: Chemistry Supplement, Immediate Change Being Effected (A-C-AI, A-C-CI, N-C-CI) and Prior Approval (A-C-AP, A-C-CP, N-C-CP).
ONADE: Fixed an issue where names containing over 25 characters were truncated within the digital signature of the administrative cover sheet included within eSubmitter submission packages.
ONADE: Fixed an issue within the Notice of Shipment template (I-B-OT) where Sub-Class and Class Other text information were inadvertently cleared when exiting and re-entering Section 1.3 "Type and Number of Animals".
ONADE: Fixed an issue where RLNAD information was incorrectly disabled within the following submission types: A-C-NL, A-C-NF, A-R-AC, A-R-CC, J-H-OT, and J-H-SP
ONADE: Removed section 4.9 "Microbiological Testing Controls" (and associated sub-sections) from the V-A-OT template, since they reference information not commonly provided within a Type V Master file.
ONADE: Fixed an issue within some CMC submissions where the purpose of submission within the administrative cover sheet was missing.
ONADE: Updated the A-Z-OM, J-Z-OM, G-Z-OM, and V-Z-OM "Z" meeting templates to reflect the meeting type, audio/visual requirement, and requested CVM participant enhancements previously incorporated in the I-Z-OM and N-Z-OM templates.
ONADE: Updated all "Z" meeting templates (I-Z-OM, N-Z-OM, A-Z-OM, J-Z-OM, G-Z-OM, and V-Z-OM) to only require the status of foreign visitors when requesting and in person meeting.
ONADE ABCT: Released INAD major technical section template: Phenotypic Characterization (TS) for use within ABCT 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 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).
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: 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.
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).
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).
(Coming Soon) ONADE: Updated I-P-EF and I-P-TS templates with improved organization for data submission.
DER: Added an important message within the "Alerts and News" tab related to the submission of Drug Experience Reports (DERs).
ONADE: Adjusted the Request for Meeting (Z) template to hide the audio/visual questions when the type of meeting selected is a teleconference.
ONADE: Added a new question to the U.S. Agent Contact Information node to distinguish between non-U.S. firms that have a U.S.-based employee instead of a U.S. Agent.
OMUMS: Fixed an issue where the template for submitting a "Request for Addition to Index - Original Request (Z/I/OR)" was not available.
ONADE: Fixed the hint text related to the list of Submission Classification Codes available for an ANADA - Supplement (C) (i.e., the Administrative Request code was incorrectly identified as NL when it should have been AD).
(Coming Soon) ONADE: Updated I-P-EF and I-P-TS templates with improved organization for data submission.
ONADE: Fixed an issue where older submissions created within FDA eSubmitter were not able to be opened.
DAF, DERS, OMUMS: Fixed an issue within templates where CVM File Specification details were not properly displayed from links associated with file attachment questions.
Adjusted the eSubmitter installer to locate the Java runtime within the application folder instead of a user temp folder. By doing so we ensure the application is fully self-contained within the application folder, as well as limiting the potential of the Java runtime being deleted by accident.
Created a new "CVM Recommended File Specifications" document providing guidance about the file types supported by CVM that can be attached within a submission. A reference to the document can be found within the eSubmitter "Helpful Tips" section of the informational screen.
ONADE: Updated all file attachment questions within the ONADE templates to reference/link the new "CVM Recommended File Specifications" document.
Added a link to open the CVM eSubmitter Preferences Guide Book from within the Preferences dialog.
Added a section to the CVM eSubmitter Packaging Quick Guide describing the generation of a batch submission. A batch submission occurs when the overall submission content exceeds 1 GB. The Packaging Quick Guide is accessible from the Packaging dialog.
Added a description of the Working Folder warning message to the CVM eSubmitter Quick Guide. The warning is displayed at start-up when there are issues identifying the working folders.
ONADE: Fixed an issue where administrative Transfer of Ownership and/or Firm Name and Address changes could not be directly submitted for unapproved ANADA's and NADA's under the General Correspondence submission types (i.e., A-G-AD, N-G-AD).
ONADE: Fixed an issue where the Reference Listed New Animal Drug information was not properly enabled within a JINAD Categorical Exclusion submission (i.e., J-X-CE).
Corrected minor typos within the CVM eSubmitter Frequently Asked Questions document.
1. Application changes implemented as part of the move from FDA eSubmitter to CVM eSubmitter:
Application name and images: Changed to reflect CVM eSubmitter
[NEW] Getting Started:
Added a new "Getting Started" dialog to help new users navigate through the process of registering for accounts, configuring the application, and preparing for their first submission.
[NEW] Application "Out of Date" Warning Message:
Added a new warning capability that will display a message when the application is more than 75 days out of date since it last received an update.
Application Registration Dialog: Removed the initial Registration dialog that did not pertain to CVM users.
Revised content to better reflect only CVM.
Added support for viewing introductory sub-sections from the Help menu when a submission is open, previously the open submission had to closed in order to view any introductory sub-sections.
Removed sections that did not pertain to CVM (i.e., Memory Settings, MedDRA Dictionary).
[NEW] Registering Accounts Quick Guide
[NEW] Preferences Quick Guide
[REVISED] Application Quick Guide
[REVISED] Frequently as Questions (FAQ)
[REVISED] Digital Signature Creation Quick Guide
[REVISED] Packaging Quick Guide
Added the application name and version to the header of the report.
Application Working Folders:
New folder created for storing the Preferences file ("user" folder), no longer included within "data" folder.
New folder created for storing the Address Book file ("addressbook" folder), no longer included within "data" folder.
Java Version: Moved to Java 1.6, no longer supporting Java 1.4
2. ONADE: The Blood Level Bioequivalence Protocol QbR template Pilot has been completed, the template was updated to reflect comments received during the Pilot period.
ONADE: Removed the "Are you submitting a labeling supplement that qualifies for a 60 day review (21 CFR 514.8(c)(2)(I)(A) or (D)?" question from A-C/R-NF submission types since it is not applicable for an ANADA application.
ONADE: Fixed an issue where the Purpose of Submission was not being generated for A-B-AR submission types.