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

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