FDA Sharpens its Focus on Regenerative Medicine Regulation - Update

Barbara Binzak Blumenfeld, Shareholder in the firm's FDA practice, recently published an article on FDA's regulation of regenerative medicine products in the Food and Drug Law Institute's (FDLI) July/August edition of Update magazine.  The article, "FDA Sharpens its Focus on Regenerative Medicine Regulation," summarizes the numerous steps that FDA has taken since fall 2016 to engage various stakeholders about the risks and benefits of stem cell therapies. It also discusses how FDA is implementing a new provision for regenerative medicine products that was enacted as part of the 21st Century Cures Act, as well as how FDA may be changing its regulatory approach toward these products in a new framework to be announced this fall.

FDLI is a non-political, non-profit organization that engages stakeholders in food and drug law "to inform innovative public policy, law, and regulations."