Guidance for Industry: How to Register with the CVM Electronic Submission System to Submit Information in Electronic Format using the FDA Electronic Submissions Gateway.

摘要

This guidance provides general standards which should be used for to register with the Center for Veterinary Medicine (CVM or the Center) Electronic Submission System (ESS) to submit information in electronic format using the FDA Electronic Submissions Gateway (ESG). FDA's guidance documents, including this guidance, does not establish legally enforceable responsibilities. Instead, guidance describing the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.