Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine Products

March 31, 2016By: Jeffrey K. Shapiro Download PDF

In the emerging world of regenerative medicine, there is a stark dichotomy in the level of regulation applied to products derived from human cells and tissues, or what FDA calls “human cells, tissue or cellular and tissue-based products” (HCT/Ps).

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