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CGT Regulatory Update and Outlook with Dark Horse Consulting's Kimberly Benton, Ph.D.
Manage episode 434382683 series 2945689
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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.
89 episoder
Manage episode 434382683 series 2945689
We love to hear from our listeners. Send us a message.
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.
89 episoder
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