The report discusses the regulatory pathway for regenerative cell therapy products, focusing on Osiris Therapeutics' Grafix product. It highlights the use of PHS sec. 361 and 21 C.F.R. Part 1271 as a 'backdoor' for marketing products without pre-market review. The report examines the criteria for minimal manipulation, homologous use, and combination with other articles, and discusses the implications for various companies in the cell therapy space.
documents/EFTA01092057.pdf
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