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DiMe Publications

Fit‐for‐Purpose Biometric Monitoring Technologies (BioMeT): Leveraging the Laboratory Biomarker Experience

DiMe’s Research Committee work group complted its first project with this publication. This manuscript addresses the need for a more robust regulatory framework that includes thorough verification, analytical validation, and clinical validation, as well as biomarker qualification evidentiary guidance from the FDA.

August 2020 in Clinical and Translational Science

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