Once you have contacted FDA, submitted a test file, and have been notified that your test file was processed successfully, you may begin submitting electronic ICSRs either via the FDA ESTRI gateway or on physical media.  

FDA ESTRI Gateway:

Submit ICSRs through the gateway during the gateway hours of operation.  See the status page for the current status of the gateway and AERS as well as the normal operating schedule.

The gateway will return an acknowledgment of receipt of the transmission when each transmissions is successfully received and decrypted.  The AERS system will return an ICH M2 compliant acknowledgment message when the ICSRs have been processed.

For more information regarding electronic submissions via the FDA ESTRI Gateway, go to the Gateway Frequently Asked Questions web page.

For Physical Media:

1.   Prepare a submission package that contains the floppy disk, CDROM or magnetic tape.

2.   Mail the submission package to the address below:

Verify that CDER received the submission package by contacting the appropriate vendor (e.g., U.S. Postal Service, Federal Express) and tracking the package according to the vendor’s guidelines.

If one or more ICSRs are not successfully loaded into AERS, CDER will contact you and assist you with resolving the issues so that you can resubmit the ICSRs that did not load properly.  Resubmission packages are handled in the same manner as the original submission.