Mary Thanh Hai

Mary Thanh Hai

Company: U.S. Food and Drug Administration

Job title: Deputy Director for Clinical, Office of New Drugs


Criteria for Acceptance of Biomarkers in Drug Development: An FDA Perspective 8:10 am

PRESENTING VIRTUALLY • Biomarkers for use in drug development programs may come to FDA through the qualification program for use in any relevant clinical development program or submitted directly to the review division for use in a particular drug development program • There are multiple types of biomarkers that can be useful in drug development…Read more

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