CVM ONADE eSubmitter Program
The Center of Veterinary Medicine’s (CVM) Office of New Animal Drug Evaluation (ONADE) has completed the CVM eSubmitter Project and developed a tool that enables the animal drug industry to voluntarily submit Investigational New Animal Drug (INAD) file submissions as well as New Animal Drug Application (NADA) submissions electronically in compliance with the commitment made during the Animal Drug User Fee Act (ADUFA II) of 2008.
The eSubmitter tool development was expanded to include all submission types submitted to ONADE. Along with the INAD and NADA submissions, the tool permits the creation and submission of Generic Investigational New Animal Drug (JINAD) files, Abbreviated New Animal Drug Applications (ANADA), Veterinary Master Files (VMF), and General Correspondence (GC) files.
The tool was made available, for voluntary use by sponsors and manufacturers in the animal health industry, on March 11, 2011. The animal health industry may now use the eSubmitter for the creation of all of their official submissions to ONADE/CVM in lieu of paper.
CVM Workshop Information
An online, public workshop was held on October 21, 2010, to introduce the CVM Beta release of the eSubmitter tool.
- The morning presentation is now available
- Questions and answers from the workshop are now available.
- The morning session of the workshop was recorded and is now available.
The eSubmitter tool, with the CVM templates, is available to download NOW. If you already have eSubmitter installed, you only need to start eSubmitter (with your computer connected to the internet) and the CVM templates will download and install automatically.
A combined FAQ and Question & Answer document that captures common questions CVM has received is available here.
For questions, please contact us at firstname.lastname@example.org
- Download FDA eSubmitter Software
(Available NOW - Final Version with CVM - ONADE templates)
Electronic Submissions Gateway Information on how to submit documents to FDA electronically.
- Guidance for Industry #108 - How to Submit Information in Electronic Format to CVM (PDF - 537KB)
108 CVM ESS Acceptance and Rejection Messages(PDF - 234KB) CVM's Electronic Submission System (ESS) Acceptance and Rejection Messages CVM eSubmitter Workshop Morning Presentation(PDF - 716KB)
- Morning Session -
CVM eSubmitter Morning session recording Workshop Q&A(PDF - 71KB) CVM eSubmitter FAQ(PDF - 52KB)
- Electronic Stability Data Standard
CVM Recommended File Specifications(PDF - 47KB)