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Focus on Regulation

Tag Archives: stem cell

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited programs available for the development and review of certain regenerative medicine therapies.  Importantly, the draft guidance clarifies certain aspects of the Regenerative Medicine Advanced Therapy (RMAT) designation established by

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies.  This initiative builds on the agency’s existing framework to set forth more clearly which products are subject to regulatory enforcement. In September, as we previously discussed here and here, FDA’s Commissioner,

D.C. Circuit Issues Landmark Ruling for Stem Cell Therapies

The D.C. Circuit has issued a ruling that will shape the future development of stem cell therapy in the United States.  Through its February 4 decision, the court has broadly upheld FDA’s authority to regulate stem cell therapies as drugs.  Thus, any sense that the development of such therapies may be exempt from the pre-market approval