Designed specifically for animal drugs, the FDA Center for Veterinary Medicine (CVM) eSubmitter program is part of the agency’s overall Electronic Document Submission and Review System. The CVM eSubmitter program is a free, question-based tool that allows animal drug sponsors to electronically and securely submit information to the center.
All animal drug sponsors must use eSubmitter to submit information to CVM’s Office of New Animal Evaluation (ONADE). The program uses templates to capture data and walk sponsors through the processing of submitting a complete and structured animal drug submission to ONADE for review. Sponsors must use eSubmitter for all submission types regardless of complexity.
ONADE’s Policy for Completing eSubmitter Submissions
According to ONADE’s policy, the eSubmitter templates are the authoritative source for all submitted information. All questions that are a required field (designated with a blue dot in the templates) must contain complete and accurate information that is consistent with any supporting documents attached to the submission. If the information doesn’t meet these standards, ONADE may refuse to review or refuse to file the submission.
eSubmitter’s standardized templates structure the necessary information in a consistent manner, which allows for a more efficient review process. When a sponsor doesn’t answer questions, the benefit of having standardized templates is nullified. Using “see attached” isn’t an acceptable answer as it forces the ONADE reviewer to search for the necessary information, which is a time burden. However, there are unique cases where the structure of the template doesn’t accurately capture the information and an answer of “see attached” IS necessary. These cases should be rare and the sponsor should contact ONADE before submitting the information.
Messages to Industry
- September 17, 2018 - Critical eSubmitter Update to Support ADUFA IV and AGDUFA III
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