E. David Litwack, PhD, Personalized Medicine Staff, Office of In Vitro Diagnostics and Radiological Health, US FDA, discussed and provided insight into the updated FDA guidance that requires an investigational device exemption for studies that use in vitro diagnostic devices and its impact on researcher studies.
Joining him for the question and answer portion of the presentations were:
- Donna Roscoe, PhD, Senior Scientific Reviewer, Office of In Vitro Diagnostic Evaluation, Center for Devices and Radiological Health, US FDA
- Yun-Fu Hu, PhD, Associate Director, Division of Immunology and Hematology Devices, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, US FDA
- Živana Težak, PhD Associate Director, Science and Technology, Personalized Medicine, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, US FDA
Presentations
Investigational device exemption, E. David Litwack
Using sequencing (and other assays) in clinical trials: FDA rules and regulations, E. David Litwack
Conference Materials
2014 Personalized medicine? Using sequencing (and other assays) in clinical trials: FDA rules and regulations: Flyer, Human Research Protection Office, Washington University School of Medicine in St. Louis
