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NOTE: The process described in the guidance above is no longer current and being rewritten.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