Commercializing Stem Cell-Based Therapies: Meeting NIH and FDA Requirements by Kalah Auchincloss


In March, President Obama signed an executive order lifting the Bush Administration restrictions on federal funding for human embryonic stem cell (HES) research. The possibility of new federal funding opportunities, in combination with more than a decade of scientific advances in both embryonic and adult stem cell research, signal that stem cell-based therapies (“SCBT”) could soon be available for patients in a clinical setting. For those wishing to commercialize such therapies, it will be important to ascertain how the U.S. Food and Drug Administration (“FDA ”), which has regulatory authority over U.S. marketing of SCBT, will exercise this oversight.

This article is not intended to be an exhaustive dissertation on all laws and regulations pertaining to stem cell research, embryonic or otherwise.1 Rather, it discusses the controversial history of federal funding for stem cell research, and then focuses on regulations and guidelines likely to govern FDA approval of clinical applications of SCBT. It also discusses some of the recent recommendations included in the International Society for Stem Cell Research Guidelines in the context of U.S. application of those recommendations.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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