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In Vitro Diagnostic/Companion Diagnostics Developments in the US and Impact on Global Programs
Session Chair(s)
Stephanie Choi, PhD
Director, US Global Regulatory and Scientific Policy (GRASP)
EMD Serono, United States
This session will present on the shifting regulatory landscape on diagnostics, including laboratory developed tests. Discussions will focus on a new proposed rule, the FDA’s oncology diagnostics pilot program, and global development implications.
Learning Objective : Explain recent developments in the In Vitro Diagnostic/Companion Diagnostics (IVD/CDx) regulatory landscape in the US; Discuss regulatory implications of the proposed rule on LDTs; Evaluate the impact of FDA IVD initiatives on global drug development programs
Speaker(s)
The LDT Rule and its Impact to CDx
Cortez McBerry, PhD
NDA Partners, United States
Partner
Top Line Trends in Diagnostics Policy in 2024
Laura DiAngelo, MPH
AgencyIQ by POLITICO, United States
Research Director
Impact of Changing IVD/LDT Landscape on Global Drug Development Programs
Megan Doyle, JD, MPH
Eli Lilly & Company, United States
Associate Vice President, Assistant General Counsel - Diagnostics
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