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Regulatory Qualification of a Cross-Disease Digital Measure : Benefits and Challenges from the Perspective of IMI Consortium…
Background: Innovative Medicines Initiative (IMI) consortium IDEA-FAST is developing novel digital measures of fatigue, sleep quality, and impact of sleep disturbances for neurodegenerative diseases and immune-mediated inflammatory diseases. In 2022, the consortium met with the European Medicines Agency…
Basel: S. Karger AG, 2023