Presentation Information
[P2-09]The Path to IDE/IVDR: Navigating the Evolving Regulatory Guidelines for Gene Therapies
*Lynn Kamen1, Luke Armstrong1, Will Williams1, Robert Nelson2, Jim McNally1 (1. BioAgilylitx Labs, 2300 Englert Drive, Durham NC 27713, USA, 2. BioAgilylitx Labs, Lademannbogen 10, 22339 Hamburg, Germany)
Keywords:
Immunogenicity,Gene Therapy,Companion Diagnostics
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