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ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation - The Niche
In the last few months the FDA has taken steps toward crystalizing regulatory oversight of stem cell and more broadly cell and tissue-based therapies. These steps come in the form of several draft guidances (see here, here, and here) . The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation. For example, ARM has … ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation Read More »
Professor Paul Knoepfler, Ph.D.