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

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