The Food and Drug Administration (FDA) has recently published a framework for the use of Digital Health Technologies (DHTs) in drug and biological product development. This framework aims to guide the use of DHT-derived data in regulatory decision-making for drug and biological products. In this article, we will discuss the key aspects of this framework and how it will impact the future of digital health technologies in the pharmaceutical industry.
As part of the FDA User Fee Reauthorization Act of 2022 and in connection with the Prescription Drug User Fee Act (PDUFA) VII, the FDA committed to establishing a framework that will guide the use of DHT-derived data in regulatory decision-making for drug and biological products. This framework is designed to address the challenges of incorporating DHTs and DHT-derived data into regulatory decision-making and to promote more efficient drug development.
DHTs offer several advantages for drug and biological product development. They can provide continuous and extensive data, enabling more accurate monitoring of patients' health and better evaluation of the safety and efficacy of new treatments. Furthermore, DHTs can help support timely access to safe, effective, and innovative new medicines for patients.
Despite their potential benefits, there are numerous challenges when incorporating DHTs and DHT-derived data into regulatory decision-making. The FDA's framework outlines a multifaceted approach to collaboratively address these challenges with stakeholders. The framework aims to guide activities such as:
- Defining objectives for workshops and demonstration projects.
- Developing methodologies for evaluating DHTs proposed as measuring key endpoints or other important measures in clinical trials.
- Managing submissions with extensive and continuous data (e.g., developing acceptable approaches to capture adverse events).
- Developing a standardized process for data management and analysis of large datasets from DHTs.
The FDA encourages public comments on the framework and has provided guidelines for submitting comments electronically or via written/paper submissions. All comments will be posted on the public docket, with confidential information protected as per the guidelines detailed in the submission instructions.
The FDA's framework for the use of Digital Health Technologies in drug and biological product development represents a significant step towards embracing the potential of digital health in the pharmaceutical industry. Through this collaborative approach, the FDA aims to advance drug development and promote public health by incorporating the latest technological advancements in the regulatory decision-making process.