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  1. FDA In Brief

FDA In Brief: FDA issues guidance to facilitate the efficient qualification of novel biomarkers that can help advance drug development

December 11, 2018

Media Inquiries

  Amanda Turney

“New medical breakthroughs are altering how diseases are treated in ways that seemed unimaginable just a decade ago. One of the most significant developments is the ability to use markers, such as proteins expressed in a person’s blood, to help identify the biological activity of a disease and patient’s response to therapy. Sometimes these biomarkers can provide a more timely and effective measure of whether a person is responding to a new medicine, improving the efficiency of drug and biologic development,” said FDA Commissioner Scott Gottlieb, M.D. “The application of using biomarkers in drug development can help lower development costs and improve efficiency of drug development programs, including potentially reducing the sample size needed to achieve statistical significance to demonstrate clinical effect or identifying potential safety signals earlier. This means that a drug can potentially get to market faster. Today, to advance these opportunities, we issued a new draft guidance that provides considerations for the kinds of evidence that can support qualifying biomarkers for use in drug and biologic development programs. This guidance is part of the FDA’s ongoing efforts to encourage medical innovation and help make sure patients have more opportunities to access effective therapy.”

Today, the U.S. Food and Drug Administration issued draft guidance for industry, Biomarker Qualification: Evidentiary Framework. This guidance provides recommendations on general considerations to address when developing a biomarker for qualification under the 21st Century Cures Act. Qualification of a biomarker is a determination that within the stated context of use, the biomarker can be relied on to have a specific interpretation and application in drug development and regulatory review.

The draft guidance describes an evidentiary framework to support qualification of a biomarker that consists of several components: describing the drug development need, defining the context of use for the biomarker, considering potential benefits if the biomarker is qualified for use and considering potential risks associated with the proposed use of the biomarker in a drug development program.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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