The report discusses the regulatory status and market potential of Osiris Therapeutics' Grafix product for diabetic foot ulcers. It covers the FDA's agreement with Osiris on the regulatory pathway for Grafix and Ovation, the implications of 21 C.F.R. Part 1271, and the criteria for minimal manipulation, homologous use, and combination with other articles. The report also mentions other companies and products in the regenerative medicine space.
documents/EFTA01092027.pdf
{}