Biomarker Guidances and Reference Materials
On this page:
- 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NOTE: The process described in the guidance above is no longer current and being rewritten.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
- Biomarker-driven Drug Development for Allergic Diseases and Asthma, February 2024
- 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