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US FDA To Explore New Regulatory Pathways For Some Cellular Products

 
• By Sue Sutter

Agency re-evaluating criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs; industry suggests a 2014 guidance which created an alternative pathway for cord blood products could serve as potential template.

Peter Marks with cellular background
CBER Director Peter Marks says FDA plans to explore whether there is an intermediate pathway between tissue regulations and a full BLA for certain cellular products. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock, Getty images

The US Food and Drug Administration is considering whether new regulatory pathways are needed for certain types of human cells, tissues, and cellular and tissue-based products (HCT/Ps).

What types of HCT/Ps might fall into this new category, and what any new regulatory pathway might look like, remains to be seen

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