24 Mar FDA outlines plan for digital health technologies for clinical trials

By Ferdous Al-Faruque, RAPS

The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year. While it has issued guidances on digital health products generally, there is still concern about whether such products are accurate and reliable enough to gather data for the drug development process.

As part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA VII), the agency published a framework on 23 March on how it plans to address long-standing questions on the use of DHTs in drug clinical trials.

The agency has established a steering committee with staff from its drug, device, and biologics review centers as well as its Digital Health Center of Excellence and its Oncology Center of Excellence to ensure consistent policies across the agency, according to the framework. Read more …