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.
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.
FDA-Cosponsored Workshops and Events
DIA/FDA Statistics 2016 Forum, April 2016
Amur S. Biomarker Qualification at CDER, FDA. Advancing the Development of Biomarkers in Traumatic Brain Injury; March 3, 2016; Silver Spring, MD.
Amur S. Biomarker Qualification. Osteoporosis Drug Development Moving Forward: Public Workshop; November 4, 2015; Silver Spring, MD.
Amur S. Opportunities to Develop Meaningful Biomarkers. IOM Workshop, October 2015.
Woodcock J. Keynote Address. M-CERSI Symposium; August 21, 2015; Baltimore, MD.
Amur S. FDA’s Efforts to Encourage Biomarker Development and Qualification. M-CERSI Symposium; August 21, 2015; Baltimore, MD.
Buckman-Garner S. Biomarker-Based Enrichment of Clinical Study Populations. M-CERSI Symposium; August 21, 2015; Baltimore, MD.
Amur S. Biomarker Qualification at CDER/FDA. EMA-FDA Webinar, May 23, 2013.
Parekh A. Drug Development Tool Qualification at CDER/FDA. EMA-FDA Webinar, May 23, 2013.
Robb MA, McInnes PM, Califf RM. Biomarkers and surrogate endpoints: Developing common terminology and definitions. JAMA. 2016;315(11):1107-1108..
Duke-Margolis Center for Health Policy. Facilitating Biomarker Development: Strategies for Scientific Communication, Pathway Prioritization, Data-Sharing, and Stakeholder Collaboration. 2016.
Amur S, LaVange L, Zineh I, Buckman-Garner S, Woodcock J. Biomarker qualification: Toward a multiple stakeholder framework for biomarker development, regulatory acceptance, and utilization. Clin Pharmacol Ther. 2015;98(1):34-46.
Amur SG, Sanyal S, Chakravarty AG, et al. Building a roadmap to biomarker qualification: Challenges and opportunities. Biomark Med. 2015;9(11):1095-1105.
Hausner EA, Hicks KA, Leighton JK, Szarfman A, Thompson AM, Harlow P. Qualification of cardiac troponins for nonclinical use: A regulatory perspective. Regul Toxicol Pharmacol. 2013;67(1):108-114.
Goodsaid F, Mattes WB, eds. The Path from Biomarker Discovery to Regulatory Qualification. 1st ed. Cambridge, MA: Academic Press, 2013.
Woodcock J, Buckman S, Goodsaid F, Walton MK, Zineh I. Qualifying biomarkers for use in drug development: A U.S. Food and Drug Administration overview. Expert Opin Med Diagn. 2011;5(5):369-374.
Dieterle F, Sistare F, Goodsaid F, et al. Renal biomarker qualification submission: A dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nat Biotechnol. 2010;28(5):455-462.
Goodsaid F, Papaluca M. Evolution of biomarker qualification at the health authorities. Nat Biotechnol. 2010;28(5):441-443.
Throckmorton DC. How a U.S. regulator can encourage new science. Clin Pharmacol Ther. 2009;86(5):471-472.
Biomarker Materials and Informational Websites
Food and Drug Administration: FDA Case Study: Biomarker Qualification – Developing and Obtaining Regulatory Acceptance of a New Biomarker (PDF - 944KB)
Food and Drug Administration: Letter of Support Initiative
Food and Drug Administration: Critical Path Innovation Meeting
Food and Drug Administration: Medical Product Development Tools
Food and Drug Administration: Biomarkers Used as Outcomes in Development of FDA-Approved Therapeutics (October 2007- December 2015)
European Medicines Agency: Qualification of Novel Methodologies for Medicine Development
Identifying Potential Biomarkers for Qualification and Describing Contexts of Use to Address Areas Important to Drug Development: Survey Results