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FDA Aims To Clarify Human Cell/Tissue Regulation With Upcoming Meeting, Guidance Documents

FDA announced an April hearing to discuss four open draft guidance documents clarifying the regulation of human cells, tissues, or cellular or tissue-based products.

FDA is making a coordinated push to shine light on appropriate regulatory pathways for the fledgling industry focused on developing products made with human cell or tissue components. It is planning an April public meeting to discuss the product category and four recently issued draft guidance documents addressing the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps).

The public meeting

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