December marks the one year anniversary of the U.S. Food and Drug Administration’s (FDA) draft guidance, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations”. Over a decade of progress drove these advancements, which is reflected by industry adoption of these tools. The Digital Medicine Society’s Library of Digital Endpoints surpassed 350 unique digital endpoints used for evaluating new medical products. Over 100 sponsors are using digital endpoints across dozens of therapeutic areas, measuring concepts from cognition to physical activity and gait to glucose levels.
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