Innovative Procedures V. Premarketing Approval

Law360, New York (September 20, 2011, 12:23 PM EDT) -- The U.S. Food and Drug Administration is increasingly scrutinizing certain novel stem cell and tissue procedures used by physicians and companies, asserting that such activities do not comply with the Food, Drug and Cosmetic Act (“FDCA”) and the Public Health Service Act (“PHSA”). One of the FDA’s first test cases is against Regenerative Sciences LLC in the United States District Court for the District of Columbia (1:10-cv-01327-RMC). The decision by the court in this case will likely dictate how this nascent industry develops.

The FDA’s position in the Regenerative Sciences case — and others that will likely follow — is that...

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