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Expert Analysis

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....

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