FDA requests comments on draft guidance for Precision Medicine Initiative

FDA requests comments on draft guidance for Precision Medicine Initiative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

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

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  To comment on this draft guidance, please visit the comment docket 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  To comment on this draft guidance, please visit the comment docket  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

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