Beyond The IND: Regulatory And Clinical Strategic Planning For Cell And Gene Therapies

Thu, Nov 22nd 2018
A successful Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT) meeting with CBER paved the way for the early product manufacturing activities and very early preclinical safety and efficacy evaluations. A pre-Investigational New Drug (Pre-IND) meeting provided additional clarity on the IND-enabling activities needed to support an initial IND submission in support of a Phase 1 first-in-human (FIH) study.
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