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drv17

10/10/21 5:20 PM

#332529 RE: falconer66a #332524

Falconer, I wish that you would send your questioning of FDA's description of using biomarkers to Dr. Janet Woodcock acting director of FDA and request them to clarify their intent.

Quote:
“The Biomarkers, EndpointS and other Tools (BEST) glossary defines a biomarker as a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. A biomarker is not an assessment of how an individual feels, functions, or survives.