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FDA Outlines Discussion Topics for Upcoming November Public Workshops on NGS Test Regulation
October 27, 2015Ahead of a two-day public workshop on regulating next-generation sequencing tests, the US Food and Drug Administration has published discussion papers outlining the approaches it is considering and has asked stakeholders for feedback on specific questions. On Nov. 12, the FDA workshop will focus on developing analytical standards for NGS testing, and on Nov. 13 the agency will discuss variant databases for clinical interpretation. Stakeholders can provide input at these workshops or in writing.