2023年10月31日 · FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other notifications. FIS has...

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CDER Direct allows users to easily create and submit data directly to the FDA. This system will provide information to FDA/CDER about drug manufacturers and private label distributors,...

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To make submissions to FDA (e.g., Food Facility Registration, Prior Notice, etc.) you must first create an account. Select "Create New Account" towards the bottom left side of this page. If …

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SSO Login for Drug Approvals and Databases. Make sure to insert your PIV card into reader, before clicking above. Request Access Send to FDA OMUF Help

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This page provides FDA ESG requirements for the use of digital signatures on FDA Forms transmitted via the Gatewa