Regulatory Discussion: Updates on FDA LDT and NGS Initiatives

Regulatory Discussion: Updates on FDA LDT and NGS Initiatives

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In late 2014, the FDA released a draft guidance document outlining potential new requirements for lab-developed testing services. The updated framework will repurpose existing medical device regulations and may impose new requirements for clinical labs, hospitals, physicians, and other health care providers. In addition, the FDA released a discussion paper and announced a public meeting on regulatory oversight of next-generation sequencing tests. Find out how the changes may affect your lab in this webinar recording. Hear from Mya Thomae, Vice President of Regulatory Affairs at Illumina.



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