Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.
Dako North America, an Agilent Technologies Company, has recent experiences with new Companion and Complementary Diagnostic assays for PD-L1, which guide physician treatment decisions for lung cancer. This presentation will highlight the interactive process between the IVD sponsor and FDA, including practical application of the draft guidance document issued by the FDA on Principles for Codevelopment of an IVD Companions Diagnostic Device and a Therapeutic Product.
Rosanne Welcher, Ph.D., MBA, RAC
Director, Global Regulatory Affairs, Companion Diagnostics
Dako North America, an Agilent Technologies Company