sábado, 20 de agosto de 2016

The FDA will host a Public Meeting on Next Generation Sequencing tests on Friday, September 23, 2016

The Food and Drug Administration will hold a public meeting on Friday, September 23, 2016 at the National Institutes of Health’s Masur Auditorium in Bethesda, MD, to obtain feedback on two recently released draft guidance documents on Next Generation Sequencing tests:
  • “Use of Standards in the Food and Drug Administration's Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases”
  • “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing-Based In Vitro Diagnostics.”
This public workshop will consist of FDA presentations to frame the goals of the workshop, moderated panel discussions, and opportunity for public comment. The presentations and discussions will focus on the content of the draft guidances, and address additional questions posed in Section V of the Notices of Availability published in the Federal Register on July 7, 2016. These Notices are available online at https://federalregister.gov/a/2016-16200 and https://federalregister.gov/a/2016-16201.
The FDA previously hosted two webinars on July 27, 2016 about Technical and Regulatory Aspects of the guidances, and Implications for Patients and Providers.
Meeting Information:
Date: Friday, September 23, 2016, 9:00am – 3:00pm ET
Location: Masur Auditorium, National Institutes of Health
9000 Rockville Pike, Bldg. 10
Bethesda, MD 20814
For more information and to register to attend, visit the Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests public meeting page. Note that in person attendance is limited and will be offered on a first come, first served basis. The meeting will also be open via webcast.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

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