FDA

FDA

IMPORTANT NOTICE: If you are using a legacy FDA ESG Portal, you can follow the support articles below. However, if you have transitioned to the ESG NextGen Portal, please contact the FDA ESG Help Desk to confirm certificate requirements for your account. Then, please follow the instructions from ESG NextGen AS2 Account Set-Up Steps to continue.

According to the latest update, submissions via Unified Submission Portal (USP) or API no longer require certificates, but if you are using an AS2 Gateway connection, you must still use digital certificates. To learn more about ESG NextGen, please refer to this FDA documentation.