Ellen Flannery

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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FDA recently published two draft guidance documents related to the development of devices that utilize next generation sequencing (NGS) technologies.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

Lab Association Petition Challenges FDA’s Authority To Regulate LDTs Under the FDCA

The American Clinical Laboratory Association (ACLA) filed a citizen petition on June 4 challenging Food and Drug Administration (FDA) authority to regulate laboratory developed tests (LDTs) as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA).  ACLA’s petition requests that FDA refrain from promulgating any draft or final guidance or rule purporting to regulate … Continue Reading
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