ARTICLE | Clinical News

Cultured cell product regulatory update

August 16, 2010 7:00 AM UTC

On behalf of FDA, the Justice Department filed a complaint for an injunction against Regenerative Sciences in the U.S. District Court for the District of Columbia after the company failed to make sufficient corrections to cGMP violations, which the agency contends "adulterated" its cultured cell product. FDA also said the product is misbranded due to lack of adequate directions for use and its failure to bear the "Rx only" symbol. The company said the lawsuit would allow it to question FDA's policy that a patient's own adult stem cells can be classified as drugs when used as part of a medical practice. ...