FDA seeks public feedback on biomarker and study endpoint glossary – Drug Information Update

FDA seeks public feedback on biomarker and study endpoint glossary

The U.S. Food and Drug Administration issued a  Federal Register notice, 21st Century Cures: Announcing the Establishment of the BEST Resource Taxonomy, to open a docket for public comment. In 2015, the FDA-NIH (National Institutes of Health) Joint Leadership Council identified the harmonization of terms used in translational science and medical product development as a priority need, with a focus on terms related to study endpoints and biomarkers. This resulted in the BEST glossary of terms. The FDA is seeking comments concerning the utility of BEST; including edits, additions and removal of terms along with a rationale supporting these proposed changes. Comments can also address the best approach for developing future iterations of the glossary. FDA has previously discussed taxonomy for biomarkers used in drug development at its public meeting on Drug Development Tool Process on December 11, 2018, and invited comment on the BEST taxonomy in guidance on the evidentiary framework for biomarker qualification published on December 12, 2018. For more information, please visit: FDA in Brief and Federal Register notice.