The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Updated the CVM eSubmitter installer to include the Java 1.8 runtime (requires a reinstall of CVM eSubmitter to move from Java 1.6 to Java 1.8).
Fixes
Fixed an issue within the CVM eSubmitter auto-updater that prevented updates through a proxy server (requires a reinstall of CVM eSubmitter to support auto-updates through a proxy server).
(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.
Fixes
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.
Fixes
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.
Fixes
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.
Introductory Screens:
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.
Preferences:
Removed sections that did not pertain to CVM (i.e., Memory Settings, MedDRA Dictionary).
Documentation:
[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
Submission Report:
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.
Fixes
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.
