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FDA Considers New Regulatory Pathways For Some Cellular Products

 
• By Sue Sutter

The US agency is re-evaluating its criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs. A 2014 guidance on cord blood products could serve a template, industry suggests.

Businessmen standing and talking on arrow backdrop. Decision concept.
• Source: Shutterstock

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. However, the agency’s public announcement that it...

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