A New Era For FDA Regulation Of Cell And Tissue Products

By Barbara Binzak Blumenfeld (July 1, 2021, 5:54 PM EDT) -- The May 31 expiration of the U.S. Food and Drug Administration's enforcement discretion period for the regulatory oversight of cell and tissue products, coupled with a June 2 decision in the U.S. Court of Appeals for the Eleventh Circuit, pave the way for the FDA to take more aggressive action against companies, clinics and individuals using cells and tissues to create FDA-regulated products.

The regulation of human cells, tissues, and cellular and tissue-based products, which fall within the larger category of products known as regenerative medicine, is a legally complex area fraught with both misperceptions and misunderstandings. It is therefore critical...

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