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FDA Issues Guidelines on NGS-Based Tests

The U.S. Food and Drug Administration (FDA) has issued two sets of draft guidelines for next-generation sequencing (NGS). The guidance documents will likely be finalized later this year or in early 2017. The reaction to the draft guidance, which total just 40 pages combined and were issued last month, has been mixed but seems to […]

The U.S. Food and Drug Administration (FDA) has issued two sets of draft guidelines for next-generation sequencing (NGS). The guidance documents will likely be finalized later this year or in early 2017. The reaction to the draft guidance, which total just 40 pages combined and were issued last month, has been mixed but seems to…

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