The US Food and Drug Administration (FDA) is planning to develop ways to better determine accuracy of predictions from regulatory testing of next-generation sequencing (NGS), according to FDA Commissioner nominee Robert Califf.
Michael Mezher states that FDA has been working on this development as part of the Obama Administration’s Precision Medicine Initiative. FDA is considering multiple approaches, such as a flexible design concept approach and a performance standards approach.
Up next, FDA will be hosting two workshops in the first quarter of 2016 to discuss further the plan and retrieve insight from the public. To read Mezher’s article on raps.org, click here. For more information about the November workshop held by FDA, click here. Need help with your regulatory path for your NGS diagnostic? Contact us.