Biomarkers at FDA
Biomarkers are a key medical product development tool capable of facilitating development of medical products and spurring innovation. When used in the right context, biomarkers have the potential to help expedite patient access to safe and effective treatments by reducing the time and cost of clinical trials while maintaining patient protections.
FDA is working to help speed the development of promising new therapeutics by developing regulatory science standards, reference libraries, research methods, and tools that are needed for integrating biomarker information into medical product development and clinical decision-making.
FDA encourages the integration of biomarkers in medical product development and approval, to facilitate the monitoring of FDA-regulated products, and their appropriate use in clinical practice. Biomarkers promise to reduce stagnation and foster innovation in the development of new medical products. A biomarker can be used as the basis for creating a routine diagnostic test for clinical use, after it has been approved as an in-vitro diagnostic. A biomarker can also be used to develop a companion diagnostic test that enables better decision-making on the use of a therapy that is tailored to the patient. The success of personalized medicine fundamentally depends on the development of biomarkers and diagnostic tests that can be used to accurately identify the patient population.
Biomarkers are not only integral to medical products, they also are very relevant to other FDA-regulated products. For example, biomarkers could play an important role across a number of FDA tobacco regulatory activities, including assessing new and modified risk tobacco products and identifying and evaluating potential product standards. The development of biomarkers can benefit the availability of new medical therapies by helping translate scientific discoveries into clinical applications.
Below are some resources that can be leveraged to further the use of biomarkers in FDA-regulated products.
Biologics
- Guidance for Industry: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions
- Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
- Guidance for Industry and FDA Staff: In Vitro Companion Diagnostic Devices
Drugs
- Biomarker Qualification Program
- Table of Pharmacogenomic Biomarkers in Drug Labeling
- Guidance for Industry: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions
- Guidance for Industry and FDA Staff: Qualification Process for Drug Development Tools
- Guidance for Industry: Use of Histology in Biomarker Qualification Studies
- Guidance for Industry and FDA Staff: In Vitro Companion Diagnostic Devices
Medical Devices
- Laboratory Developed Tests
- Companion Diagnostics
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)
- Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
- Guidance for Industry and FDA Staff: In Vitro Companion Diagnostic Devices