Webinar - Next Generation Sequencing (NGS) Draft Guidances: Technical and Regulatory Aspects - July 27, 2016

On July 27, the FDA will host two webinars about draft guidances released July 6, which propose methods to streamline oversight of Next Generation Sequencing (NGS)-based tests:

• “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases”
• “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics”

These two draft guidances are part of the FDA’s participation in President Obama’s Precision Medicine Initiative (PMI), which aims to take advantage of the progress made in genomic testing to accelerate the development of new treatments that take into account individual differences in people’s genes, environments, and lifestyles.

12:00 – 1:00 p.m. ET: “Next Generation Sequencing Draft Guidances: Technical and Regulatory Aspects,” will focus on the technical and regulatory aspects of the guidances.

1:30 – 2:30 p.m. ET: “Next Generation Sequencing Draft Guidances: Implications for Patients and Providers,” will address the significance of these guidances for patients and health care professionals.

Webinar Details:

Details for the webinar on Implications for Patients and Providers are available in a separate announcement.

Next Generation Sequencing Draft Guidances: Technical and Regulatory Aspects
Date: July 27, 2016
Time: 12:00 – 1:00 p.m. ET

To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.
NOTE: You must dial-in to hear the presentation and ask questions:
Dial: 888-982-4617 passcode: CDRH
International: 1-312-470-7331 passcode: CDRH

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PW9346232&p=CDRH2&t=c
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

NOTE: The FDA will not provide Continuing Education Credits (CEU) or Certificates of Attendance for these webinars.

If you have general questions about these guidances, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health