Biologics

U.S. Stem Cell Defends Practices in Appeals Court

U.S. Stem Cell, Inc., Sunrise, FL, says it argued 1/13 before the 11^th Circuit Court of Appeals that it should be allowed to present evidence and testimony in support of its position and practices in a trial. The case involves a 5/9/18 FDA suit against the company and other similar firms to prevent them from using the stromal vascular fraction (SVF) surgical procedure in which cells are removed from a patient’s fat tissue and reimplanted in the patient during the same surgical procedure.

The company maintains that such cellular therapies are surgical procedures regulated by state law and that the SVF procedure is excepted from regulation under the Federal Food, Drug, and Cosmetic Act.

A Florida federal court ruled in favor of the government on 6/25/19 and U.S. Stem Cell appealed on 8/23/19.

Before the 11^th Circuit, company attorneys argued that the SVF procedure is not subject to regulation under a 2001 FDA rule that provides an exception for a procedure in which cells are removed from and implanted in the same patient during the same surgical procedure. FDA has argued, the company says, that the exception does not apply because the reimplanted cells are not in their original form.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome