The 21st Century Cures Act added a section to the FD&C Act to promote the qualification of drug development tools, including the qualification of biomarkers for use in drug development. Readers will recall my previous post on the FDA’s biomarker qualification program including an example of a qualified biomarker. To enhance the program, CDER and CBER released a draft guidance in December 2018 intended to provide recommendations on the evidence needed to successfully qualify a biomarker. This evidentiary framework includes evaluating the need for the biomarker in drug development, defining its Context of Use (COU), assessing its risks and benefits, and developing a supporting data package. The guidance points out that qualification of a biomarker is a distinct process from the process to grant clearance or approval of a diagnostic device in clinical practice, a concept that may be confusing as the regulations seem to overlap. Analytical validation of the methods for measuring or quantifying data for use in the biomarker is discussed in detail and statistical methods for evaluating the association of the biomarker with the clinical outcome of interest are reviewed. The draft is open for comment until 11FEB2019 under Docket 2018-26900.

Text Copyright © 2019 Katrina Rogers