P329: Tracking Digital Health Technologies (DHTs) in IND, NDA, and BLA Submissions: A CDER Case Study
Poster Presenter
Ayoub Suliman
Regulatory Health Project Manager
FDA United States
Objectives
Describe FDA CDER’s approach to identify and classify DHT-related submissions and report trends from March 2023 through December 2025 in alignment with PDUFA VII commitments.
Method
In March 2023, FDA updated Forms FDA 1571 and FDA 356h to enable Sponsors to flag DHT-related submissions in FDA’s application systems. CDER’s Office of Medical Policy adjudicates Sponsor-flagged submissions using an internal dashboard tool to remove errors/duplicates and to categorize submissions.
Results
CDER’s Office of Medical Policy established a tracking and reporting process that generates a validated, high-integrity dataset of confirmed DHT-related submissions. The dataset includes clinical trial documents (e.g., protocols, statistical analysis plans, clinical study reports) involving sensor-based DHTs and electronic Patient-Reported Outcomes (ePROs). The dataset enables trend analysis across three key categories: (1) regulatory submission type (IND vs. NDA or BLA) to gauge the stage of drug development, (2) modality mix and range from ePROs to sensor-based DHTs, and (3) distribution across CDER review divisions to detect therapeutic areas that most frequently incorporate DHT-enabled endpoints.
Conclusion
This case study demonstrates a systematic, approach to identify and track DHT-related submissions and reports trends in the number and rate of change of submissions utilizing DHTs fulfilling a PDUFA VII commitment and measuring the growth of digital tools in the drug review pipeline. The identification, adjudication, and categorization process improves consistency, supports awareness of the landscape of DHT-related submissions, and informs policy and engagement strategies. To promote complete tracking and facilitate efficient engagement with FDA, sponsors are encouraged to (1) accurately complete the DHT remote data field on the updated Forms FDA 1571 (Form Field 12B) for INDs and FDA 356h (Form Field 25) for NDAs and BLAs and (2) leverage FDA guidance for industry, investigators, and other stakeholders Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (December 2023) as a resource in preparing DHT-related submissions to FDA.
