FDA director sees biomarkers as key to powering precision medicine

As well as acting as the regulator to make sure therapies are safe and effective, the US Food and Drug Administration (FDA) is helping to bring precision medicine to people living with diseases that have specific genetic features.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), has underlined that the CDER has approved more than 25 new drugs that benefit patients with specific genetic characteristics in the last three years.

Writing a column for the official FDA blog, she notes that the recent progress of two drugs, in particular, show that this approach to disease treatment that tailors treatments to patients’ individual needs, is starting to come of age.