Supporting the President's Precision Medicine Initiative, the U.S. Food and Drug Administration (FDA) has issued two draft guidances to provide a streamlined approach to the oversight of tests that detect medically important differences in a person's genome. These new sequencing technologies examine millions of DNA variants at a time, requiring new regulatory oversight. The FDA encourages public comments on the guidances during a 90-day comment period.
Please Note: The 90-day comment period is now open and ends October 6, 2016 at 11:59 p.m. Eastern.
Last Updated: October 4, 2016