FDA Regulation Catches Up To Next-Gen Gene Sequencing
Law360, New York (September 23, 2015, 11:43 AM EDT) -- On Sept. 9, the U.S. Food and Drug Administration announced plans to host two public workshops on "next-generation sequencing" (NGS) that may provide greater clarity regarding the regulatory framework for personalized medicine and the use of individuals' genetic information to predict disease and develop customized treatments. The FDA is holding the workshops on Nov. 12-13 to obtain feedback and information from stakeholders on (1) approaches to developing performance and evidentiary standards for NGS and (2) the use of curated third-party databases of human genetic information to support product approvals and other Agency functions. The FDA will accept written comments on these issues until Nov. 25.[1]...
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