:loudspeaker: Upcoming Scheduled Maintenance

Please be advised that this application will be unavailable due to scheduled maintenance from June 18, 2026 at 5:00 PM ET through June 21, 2026. During this time, users will not be able to access the system. Please plan your work accordingly. We apologize for any inconvenience and appreciate your patience.

U.S. Department of Health and Human Services

National Institutes of Health

National Center for Advancing Translational Sciences

Subscribe

This article shares the team’s insights on early planning and navigating regulatory requirements for gene therapy development. It highlights the value of a target product profile and INTERACT meeting with the FDA.

Human Gene Therapy | March 6, 2025