Stakeholder Engagement with FDA

FDA encourages stakeholders who are considering the use of Digital Health Technologies (DHTs) in drug development or conducting decentralized clinical trials (DCTs) to engage the agency early.

DHT Programs- Engaging FDA

DHTs for a specific drug development program

Sponsors of applications who are considering the use of DHTs for a specific drug development program, should contact the therapeutic review division and request that a representative from the DHT Steering Committee participate in the discussions. Sponsors are encouraged to meet with FDA early.

In addition, please include in your cover letter that your submission contains DHT-derived data.

General questions on the use and feasibility of DHTs not associated with a drug development program

Sponsors or other stakeholders who are considering the use of DHTs not associated with a specific drug development program and would like to discuss general feasibility for their proposed DHT or have general questions about the potential use of their DHT should email DHTsforDrugDevelopment@hhs.fda.gov.

Sponsors or other stakeholders interested in learning more about the FDA Drug Development Tools Qualification Program should visit DDT Qualification Program for more information.

DCT Programs- Engaging FDA

Sponsors of applications or other stakeholders who are considering innovative approaches to clinical trials to include activities where some or all of the trial-related activities occur at locations other than traditional clinical trial sites are encouraged to meet with FDA early.

If the innovative approach is directly related to a therapeutic area, contact the related therapeutic review division and request that a representative from the DHT Steering Committee participate in the discussions.

Sponsors or other stakeholders who would like to discuss general feasibility of such approaches are welcome to contact the DHTsforDrugDevelopment@hhs.fda.gov.