Cell & Gene: The Podcast

CGT Regulatory Update and Outlook with Dark Horse Consulting's Kimberly Benton, Ph.D.

Erin Harris Episode 83

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Applications (BLAs) of recent approvals and complete responses for novel products or rare diseases as well as BLAs currently under review. Benton shares information about FDA Draft Gudiances, including Platform Technology Designation Program for Drug Development: Guidance for Industry. She also provides a regulatory outlook for CGT developers.

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