A Closer Look at Context of Use

Dr. Shashi Amur, from FDA’s Center for Drug Evaluation and Research, explains the concept of context of use in biomarker qualification. The context of use is central to biomarker qualification and describes appropriate use of the biomarker, how the qualified biomarker is applied in drug development and regulatory review, and criteria regarding the circumstances under which the biomarker is qualified. Through CDER’s Biomarker Qualification Program, a biomarker, once qualified for a particular context of use, becomes publically available and can be applied in any applicable drug development program.
Learn more about FDA’s biomarker qualification program at www.fda.gov/bio...