• 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NOTE: The process described in the guidance above is no longer current and being rewritten.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

Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation, November 2023.

Use of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic NASH Trials, September 2023

Identification of Concepts and Terminology for Multi-Component Biomarkers, March 2022

Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices, June 2019

Defining an Evidentiary Criteria Framework for Surrogate Endpoint Qualification, July 2018

Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices, June 2017

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

 

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: Glossary

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 Development

Critical Path Institute (C-Path)

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

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