Two FDA Webinars: Precision Medicine and Guidances for Next Generation Sequencing Tests on Wednesday, 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 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 (NGS) Draft Guidances: Implications for Patients and Providers,” will address the significance of those guidances for patients and health care providers.

More information about the webinars is available at http://www.fda.gov/CDRHwebinar.

Food and Drug Administration
Center for Devices and Radiological Health