On Tuesday, March 31, FDA published a Request for Information seeking input on the use of digital health technologies (“DHTs”) in clinical investigations for drugs and biological products (the “RFI”). Building on commitments under PDUFA VII and prior Agency publications – including a March 2023 Discussion Paper and December 2023 Guidance – FDA’s Centers for Drug Evaluation and Research (“CDER”) and Biologics Evaluation and Research (“CBER”) are looking to better understand the opportunities and challenges of using DHTs in clinical investigations of drugs and biological products. Feedback on the RFI will inform FDA’s development of future guidance and other Agency activities in this area.
The RFI highlights considerable technological advances since 2023, including the expanded range of sensors and the clinical features they can measure, gamification as a strategy for engaging pediatric patients in clinical tests, and the growing role of machine learning in the development of algorithms for DHTs to measure clinical features. To help advance the use of DHTs in drug and biological product development and review, FDA poses the following questions:
- What regulatory challenges do DHT manufacturers, sponsors, or other interested parties face regarding the use of DHTs in clinical investigations of drugs and biological products?
- What opportunities are there for CDER and CBER to support and facilitate the adoption of DHTs in clinical investigations of drugs and biological products?
- What areas of guidance would support the use of DHTs in clinical investigations?
- What specific DHT related topics, such as digitally derived endpoints in certain disease areas, would benefit from discussion in a public workshop?
Comments must be submitted by June 1, 2026. Please feel free to contact Covington’s Digital Health team with questions.