FDA Clarifies Electronic Submission of Veterinary Product Applications

he Center for Veterinary Medicine (CVM) at the FDA has been accepting applications for new products electronically for a few years. But since CVM applications and documents follow a very different format compared to those for the human drugs and biologics, it has been confusing for companies to understand the acceptable electronic submission process. A new guidance document released this week addresses this issue with detailed description of CVM’s Electronic Submission System (ESS) that resides within the Electronic Submission Gateway (ESG) used for all other electronic submissions to the FDA. There are a few differences between submission to CVM and other centers at the FDA. The submitters must separately activate their ESS account, in addition to the ESG account. The ESS account activation requires mailing physical letters of authorization and Adobe PDF signature validation. Once the CVM ESS is activated, the submitters can upload files like submissions to the other centers. CVM follows submission acknowledgement and acceptance for review receipts in a three-step process which looks very similar to the one followed by the Center for Biologics (CBER). Most of the electronic submission process thereafter is similar to the submissions to other centers. The guidance document lists the steps in the account set-up, verification, submission, and follow-up which mostly looks familiar.