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FDA issues guidance to speed cell and gene therapy development

A photo of a blue gloved hand picking out a specimen from a white tray of clinical samples with green and red lids.
Photo: Matthew Horwood/Getty Images

Kevin Kinsella

1 min read
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The guidance demonstrates how therapy sponsors can build on existing science to reduce redundant testing and accelerate treatments.

Aiming to help developers bring cell and gene therapies to patients more efficiently using existing scientific and regulatory knowledge, the US Food and Drug Administration (FDA) has released new draft guidance. The agency said the approach is designed to reduce redundant testing and streamline submissions, particularly for treatments targeting

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