display:none
Skip to main content

New, free course on capturing the value of V1C for healthcare!

Join FDA and DiMe during a 2-day virtual event.

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

Join our next project

Help streamline the path to regulatory and commercial success to optimize health outcomes for the greatest number of patients

Join the Integrated Evidence Plans project

Join us
Not today