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FDA requests comments on draft guidance for Precision Medicine Initiative

Sequence data and a DNA double helixSupporting 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.

FDA News Release

FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests External Link

Draft Guidances and Comment Links

For Stakeholders and Food and Drug Administration Staff

Please Note: The 90-day comment period is now open and ends October 6, 2016 at 11:59 p.m. Eastern. 

Public Workshop

September 23, 2016 Public Workshop - Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests 

 

Last Updated: October 4, 2016