Tag Archives: next-generation sequencing

FDA Publishes Two Draft Guidances on Next Generation Sequencing Technology

FDA recently published two draft guidance documents related to the development of devices that utilize next generation sequencing (NGS) technologies. These two draft guidances support the Administration’s Precision Medicine Initiative (PMI), which is intended to promote technologies that use genetic, environmental, and other data to tailor health care tools to unique needs of individual patients.  … Continue Reading

FDA Is Exploring Options for Regulating Next Generation Sequencing Diagnostic Tests

On December 29, 2014, FDA issued a public workshop notice and associated discussion paper entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests–Preliminary Discussion Paper.”  The Discussion Paper describes opportunities and regulatory challenges presented by next-generation sequencing (NGS) tests, and requests public comment on possible new approaches to demonstrating analytical performance and clinical … Continue Reading