The FDA has finalized their timeline for moving to their NextGen Submission Gateway. As a result, all electronic submissions through the gateway will begin flowing through the new gateway on April 15, 2025 following a brief pause in submissions. Honeywell will take additional steps to ensure the NextGen Submission Gateway is operating properly by extending the downtime. The detailed schedule can be found below. Following the maintenance window, Honeywell will closely monitor submissions to ensure there are no issues.
Schedule: Start: April 11, 2025 at 12:00 PM EDT End: April 15, 2025 at 12:00 PM EDT
Duration: 96 hours (4 days)
Service Availability: TWD Complaints integration with the FDA will be unavailable. All other TWD services will remain operational.
Customer Action: Please refrain from EMDR submissions during this maintenance window.
Notes: Please work with your Customer Success Manager if you have any questions or concerns regarding this maintenance activity.
Posted Mar 28, 2025 - 08:33 EDT
This scheduled maintenance affects: US Region - Production Environment (TrackWise Digital FDA Gateway).