The Food and Drug Administration is announcing the following public workshop entitled: “Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests”. The purpose of this workshop is to obtain feedback on two FDA draft guidances, “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” and “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics” that describes new approaches to regulate NGS-based tests.
- Date, Time and Location
- Federal Register Notice
- Webcast
- Agenda
- Registration
- Contact Us
Date, Time and Location
This meeting will be held September 23, 2016, beginning at 9:00 am – 3:00 pm at the following location:
National Institutes of Health (NIH) Campus
9000 Rockville Pike
Bldg. 10, Masur Auditorium
Bethesda, MD, 20814
[email protected].
For questions regarding workshop content please contact:
David Litwack, Center for Devices and Radiological Health, Food and Drug Administration, Office of In vitro Diagnostics and Radiological Health, 10903 New Hampshire Ave, Bldg. 66, rm. 4548, Silver Spring, MD 20993, 301-796-6206, email: [email protected].