FDA Releases Draft Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while mitigating health risks. During the public health emergency, clinical trials have run into challenges ranging from quarantines to site closures, travel limitations, supply chain interruptions, and possible infection by either the site personnel or trial participants.[1] Throughout the pandemic, FDA has recognized that it may need to make modifications to protocol-specified procedures; and digital health technologies (DHTs) came to the rescue in clinical trials, assisting with remote data acquisition.

Read the full article.