Biomarker Guidances and Reference Materials

Guidance Documents
Recent FDA-Cosponsored Workshops and Events
Biomarker Materials and Informational Websites
Biomarker Survey

Guidance Documents

Qualification Process for Drug Development Tools: 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NOTE: The process described in the guidance above is no longer current and being rewritten.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:

21st Century Cures Act: Qualification of DDT,
Resources for Biomarker Requestors: Get Started With Your Submission
Biomarker FAQ’s
BEST Glossary
Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry (PDF - 126 KB): Describes scientific standards recommended for nonclinical studies using histopathology to support biomarker qualification.

Recent FDA-Cosponsored Workshops and Events

DIA/FDA Statistics 2016 Forum, April 2016

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

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

Collaboratively Building a Foundation for FDA Biomarker Qualification, December 2015

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

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

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

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

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