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CBER Implements Pre-Clinical Meeting Program For Biologics, Gene Therapy Sponsors

 
• By Derrick Gingery

INTERACT program will allow sponsors to ask FDA questions about manufacturing and other technical issues to help streamline development.

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Biologics sponsors now have a formal program to meet with FDA reviewers during early pre-clinical development stages.

The Center for Biologics Evaluation and Research announced June 22 that it has implemented the Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) program, which is intended to help accelerate

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