FDA Migration to NextGen, AS2 for Medwatch Submissions Impacted

Scheduled for Apr 11, 21:00 PDT - Apr 14, 06:00 PDT

Scheduled

The FDA's announced system migration to NextGen is scheduled for April 12 (12:00 AM ET) – April 14, 2025 (9:00 AM ET). No submissions are supported during this period. The FDA has confirmed that AS2 will be supported post-ESG NextGen go-live. Current file naming conventions and digital certificates will remain unchanged for AS2 submissions.

Propel currently uses AS2 for MedWatch submissions.

The FDA will continue to support AS2 submissions, but the AS2 endpoint must be updated to the ESG NextGen endpoints:
- Production submissions: https://uploadapi-esgng.fda.gov:4080/as2/receive
- Test submissions: https://upload-apiesgng.fda.gov:4080/as2/receive/test

Propel has successfully performed AS2 UAT test submissions per FDA guidance NextGen AS2 UAT Guide: https://esgng-uat.preprod.fda.gov/assets/documents/AS2%20Setup%20Instructions.pdf
Summary Test Results available upon request.

We apologize for any inconvenience. For more information, or if you have any questions, please contact the Support Team at support@propelsoftware.com.

Posted Mar 31, 2025 - 16:25 PDT

This scheduled maintenance affects: Integrations (FDA Medwatch Integration).