FDA CDER developed the videos and podcasts on this page to provide stakeholders with a better understanding of biomarkers, why they are important in drug development, and the role of the Biomarker Qualification Program.

These videos and podcasts with FDA experts help stakeholders who are interested in biomarker research and development to better understand FDA’s Biomarker Qualification Program.

About FDA’s Biomarker Qualification Program

Making Biomarker Development Successful

What Are Biomarkers and Why Are They Important?

What Do You Need to Consider When Qualifying a Biomarker?

Biomarker Terminology: Speaking the Same Language

How Biomarkers Can Improve the Drug Development Process

Pathways for Using Biomarkers In Drug Development

What Does Biomarker Qualification Do (and Not Do)?

Opportunities to Engage With the FDA About Qualification During Biomarker Development

The Biomarker Qualification Process: A Roadmap for Requestors

The Role of Consortia