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Focus on Regulation

Tag Archives: regenerative medicine

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate Sterility Assurance

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning letter issued to U.S. Stem Cell Clinic located in Sunrise, FL.  FDA issued the warning letter following an inspection beginning in April

FDA Seizes Stem Cell Therapy—A First of Many?

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the disease—that were discovered during an FDA inspection at StemImmune Inc., a San Diego, California company that purports to specialize

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