ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation
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 The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation.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ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation Read More »