Regenerative Sciences musculoskeletal news
A judge in the U.S. District Court for the District of Columbia said Regenerative Sciences' cultured cell product is adulterated and misbranded and issued a permanent injunction preventing the company from manufacturing and selling the product until the company makes corrections to cGMP violations. According to the order, the term "drug" refers to any human cell, tissue, or cellular or tissue-based product, which covers Regenerative Sciences' cultured cell product.
In 2010, the Justice Department filed a complaint for the injunction on behalf of FDA after Regenerative Sciences failed to make sufficient corrections to cGMP violations. At the time, 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 (see BioCentury, Aug. 16, 2010). ...