Last updated: October 04, 2016
FDA requests comments on draft guidance for Precision Medicine Initiative
FDA requests comments on draft guidance for Precision Medicine Initiative
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.
FDA News Release
Draft Guidances and Comment Links
For Stakeholders and Food and Drug Administration Staff
- Use of Public Human Genetic Variant Databases To Support Clinical Validity for Next Generation Sequencing-Based In Vitro Diagnostics
To comment on this draft guidance, please visit the comment docket
- Use of Standards in the FDA Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases
To comment on this draft guidance, please visit the comment docket
Please Note: The 90-day comment period is now open and ends October 6, 2016 at 11:59 p.m. Eastern.
Public Workshop