DC Circ. Opens Door For Stem Cell Regulation By FDA

Law360, New York (March 7, 2014, 5:02 PM EST) -- When is the use of autologous stem cells in a medical procedure subject to regulation by the U.S. Food and Drug Administration? This question was at the forefront of a statutory injunction proceeding brought by the FDA against Regenerative Sciences LLC in August 2010 in the U.S. District Court for the District of Columbia.

The court ultimately decided that the stem cell products at issue were a drug under the Federal Drug and Cosmetic Act and/or a biologic drug under the Public Health and Safety Act...
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