The FDA's Pharmacogenomics Biomarkers in Labeling

Currently, the FDA includes pharmacogenomic warnings on the labels of more than 200 medications and the evidence is continually growing. The FDA’s Table of Pharmacogenomic Biomarkers in Labeling is attached.

FDA Table of Pharmacogenomics Biomarkers in Labeling

The FDA’s Genomics and Targeted Therapy Group is located within FDA’s Office of Clinical Pharmacology and works to apply pharmacogenomics and other biomarkers in drug development and clinical practice. FDA scientists work in multiple ways to ensure that pharmacogenomic strategies are applied appropriately in all phases of drug development. Core functions include regulatory review, research, policy development, and education and outreach.

For more on the Genomics and Targeted Therapy Group: