August 14, 2020

The Niche

Knoepfler lab stem cell blog

USA v Regenerative Sciences

3 min read

A long-standing debate in the commercial stem cell arena has focused on whether stem cells grown in a lab prior to clinical use as a transplantation product are biological drugs subject to full FDA vetting. The alternative view has been that such stem cell products are not drugs, but rather are simple human cellular and tissue products. That debate, at least operatively, would seem to be over with a ruling today by the federal D.C. Court of Appeals supporting the FDA position that stem …Read More

3 min read

What can clouds tell us about a stem cell legal court case strategy such as USA v. Regenerative Sciences? It turns out, quite a lot. In about a week a Federal Appeals Court Case will begin to review the ruling in the USA v Regenerative Sciences that favored the FDA. This is arguably one of the most important stem cell-related court cases in years and could have as far reaching implications as the Sherley v Sebelius Case, but of course in a different way. …Read More