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  4. Drug Development Tool (DDT) Qualification Programs
  5. CDER Biomarker Qualification Program
  6. Biomarker Guidances and Reference Materials
  1. CDER Biomarker Qualification Program

Biomarker Guidances and Reference Materials

Guidance Documents

Qualification Process for Drug Development Tools (PDF - 499 KB): Describes the process for qualifying drug development tools intended for potential use, over time, in multiple drug development programs.

NOTE: The process described in the guidance above is no longer current and being rewritten. A new guidance will be published as soon as possible. For more information on the biomarker qualification process described in the 21st Century Cures Act please see:

Recent FDA-Cosponsored Workshops and Events

DIA/FDA Statistics 2016 Forumdisclaimer icon, April 2016

Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshopdisclaimer icon, April 2016

Advancing the Development of Biomarkers in Traumatic Brain Injury, March 2016

Collaboratively Building a Foundation for FDA Biomarker Qualificationdisclaimer icon, December 2015

Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: An IOM Workshopdisclaimer icon, October 2015

Facilitating Biomarker Development and Qualification: Strategies for Prioritization, Data-sharing, and Stakeholder Collaborationdisclaimer icon, October 2015

Evidentiary Considerations for Integration of Biomarkers in Drug Development Symposiumdisclaimer icon, August 2015

Advancing the Use of Biomarkers and Pharmacogenomics in Drug Developmentdisclaimer icon, September 2014

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Biomarker Materials and Informational Websites

Biomarker Qualification Program

The BEST (Biomarkers, EndpointS, and other Tools) Resource: Harmonizing Biomarker Terminology (PDF)

BEST (Biomarkers, EndpointS, and other Tools) Resource: Glossarydisclaimer icon

Resources for Biomarker Requestors

FDA: Letter of Support Initiative

FDA: Critical Path Innovation Meeting

FDA: Medical Product Development Tools

European Medicines Agency: Qualification of Novel Methodologies for Medicine Developmentdisclaimer icon

Critical Path Institute (C-Path)disclaimer icon

Biomarker Survey (Published February 13, 2015)

Identifying Potential Biomarkers for Qualification and Describing Contexts of Use to Address Areas Important to Drug Development: Survey Results

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