FDA Maps Out Novel Path For NGS Market Access
This article was originally published in The Gray Sheet
FDA Commissioner Robert Califf says the agency has worked with NIH and other experts as part of President Obama's Precision Medicine Initiative to map out a new regulatory framework for next-generation sequencing. He said two new draft guidances are meant to help get such tests to market sooner without requiring developers to validate individual genetic variations.
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US FDA is holding a workshop at NIH headquarters on Sept. 23 to get public feedback on two important draft guidances that provide sponsors with more clarity on the agency's thinking on next-generation sequencing tests.
Two recent next-generation sequencing draft guidances have been positively received so far by industry and clinical research groups. But for FDA's ideas to play out, more databases will need to be populated and more standards developed, agency officials say. There are also more guidances to come on different types of NGS tests. Read our coverage below, and also listen to our podcast interview with FDA's Elizabeth Mansfield.