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ESG NextGen Is Coming: Key Milestones, Blackout Dates & What You Need to Know

Mar 28, 2025 | Drug & Biologic Product Submissions, Life Sciences, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics

As part of ongoing enhancements to streamline data exchange and compliance processes, the ESG NextGen platform is preparing to go live this spring. We’re sharing a quick overview of the key milestones and what they mean for you especially as we approach the submission blackout period from April 12 to April 14, 2025. 

Key ESG NextGen Milestones

Here’s a breakdown of the important dates you should be aware of. The full timeline is on the FDA website.

  • Testing Period: Ongoing through early April 2025
    • We’re actively participating in ESG NextGen testing to validate our systems and ensure a smooth transition.
  • Submission Blackout Dates: April 12, at 12:00 a.m. – April 14, 2025, at 9:00 a.m. (EDT)
    • During this time, the ESG system will not accept any submissions. This is a planned downtime to support the final migration to the new platform.
    • Please plan accordingly to avoid any disruptions to your submissions.
  • Go-Live: April 14, 2025 at 9:00 a.m.
    • ESG NextGen will officially be live, with enhanced functionality and improved reporting capabilities.

Please note: These dates and timelines may be affected if a government shutdown occurs.

    ✅ What This Means for You

    We understand that changes to submission systems can feel disruptive—but rest assured, we’ve got it covered.

    Our team is actively working behind the scenes to ensure our AS2 connection is fully configured and tested for ESG NextGen. We’re committed to maintaining business continuity and minimizing any impact on your workflows.

    You can expect:

    • No action is required on your end at this time
    • Continued updates as we progress through implementation
    • Timely communication around any key developments or required next steps

    Stay in the Loop

    We’ll be sharing updates through our regular communication channels leading up to and following the transition. If you have questions or concerns, don’t hesitate to reach out to your account representative or support contact.

    Thank you for your continued partnership and trust as we prepare for this important milestone. We’re excited about the improvements ESG NextGen brings—and we’re here to make the transition as seamless as possible for you.