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CBER Launches Program to Meet With Sponsors to Advance Early Product Development
Drugs Regulatory Affairs
In an effort to provide potential sponsors advice on critical topics for early drug development, CBER launched its Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) meetings program.
INTERACT meetings replace the pre-pre-IND meeting process for all products across CBER. However, they do not replace formal meetings for specific products like pre-IND meetings or pre-BLA meetings that occur in later parts of development.
Questions asked during INTERACT meetings should focus on topics related or similar to preclinical testing requirements, aspects of manufacturing required for first-in-human trials, device or assay design considerations and initial clinical development strategies.