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FDA解读临床Biomarkers，和部分热点Biomarkers

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The Biomarker Qualification Program was established to support the Center for Drug Evaluation and Research’s (CDER's) work with external stakeholders to develop biomarkers that aid in the drug development process. Through the FDA’s Biomarker Qualification Program, you may request regulatory qualification of a biomarker for a particular context of use in drug development.

Biomarkers can be used in a variety of settings, including basic research, drug development, and clinical practice. The Biomarker Qualification Program focuses on biomarkers used in drug development. Once a biomarker is qualified, it can be used in any drug development program under the context for which it obtained qualification.

The Biomarker Qualification Program is one of the Drug Development Tools (DDT) Qualification Programs created by CDER to provide a framework for development and regulatory acceptance of scientific tools for use in drug development programs.

Why qualify a biomarker through the CDER Biomarker Qualification Program?

A qualified biomarker can be used in multiple drug development programs without a need for CDER to reconfirm the suitability of the biomarker’s qualified context of use and has the potential to advance public health by streamlining the drug development paradigm.

What is the process to qualify a biomarker?

The biomarker qualification process consists of three stages: (1) Initiation, (2) Consultation and Advice, and (3) Review.