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  1. CDER Biomarker Qualification Program

More About Biomarkers & Qualification

The Biomarker Qualification Program provides a framework for the development and regulatory acceptance of biomarkers for use in drug development programs. Review the information below to learn more about biomarkers, their uses in drug development, and qualifying a biomarker through the Biomarker Qualification Program.

About Biomarkers

  • What is a biomarker?
  • Biomarker Categories: BEST Glossary
  • How can biomarkers improve the drug development process??
  • How are biomarkers qualified in the 21st Century Process?

Watch What Are Biomarkers and Why Are They Important?.

Pathways for Biomarker Integration in Drug Development

  • What are the regulatory pathways used in the Center for Drug Evaluation and Research (CDER) to integrate biomarkers into drug development?
  • What is the difference between CDER’s and the Center for Devices and Radiological Health’s (CDRH’s) qualification programs?
  • Are there any additional pathways for having a discussion about biomarkers with CDER?
  • What is a Letter of Support (LOS)?

Qualifying a Biomarker through the Biomarker Qualification Program

  • What is the FDA Biomarker Qualification Program (BQP)
  • What does the qualification of a biomarker mean?
  • Are only newly developed biomarkers eligible for qualification?
  • Does a biomarker have to be qualified to be used in drug development?
  • If a biomarker has previously been used to support claims in drug labeling, does it mean that the biomarker is qualified?
  • Does qualification of a biomarker also qualify the specific test performing the biomarker measurement?
  • Can different assays, tests, or methods be used by drug sponsors when using a qualified biomarker in an IND/NDA/BLA?

Watch Making Biomarker Development Successful.

Context of Use for Biomarker Qualification

  • What is a context of use (COU) for a biomarker?
  • Examples of biomarker intended use in drug development?
  • Examples of COUs?

BEST (Biomarkers, Endpoints, and other Tools) Resource

BEST is a “living” glossary of terms used in biomarker qualification science and medical product development..

Important Information for Requestors

Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov