Biologics

Stem Cell Therapy Firm Marketing Unapproved Cellular Products

The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by Stem Cell Therapy of Las Vegas, Las Vegas, NV, and other online sources determined that the company markets to consumers cellular products derived from either human adipose tissue or umbilical cord. An 8/5 Notice of Violations says the firm markets its products to treat various diseases or conditions, including some that are serious or life-threatening.

The notice says the firm’s products are regulated as drugs and biologic products and require an approved BLA or IND to be legally marketed.

FDA also says its review found that the firm also appears to market exosomes and, as a general matter, exosome products intended to treat diseases or conditions in humans are also regulated as drugs and biological products.

“The materials reviewed and other information available to FDA reveal that you market your cellular products and exosomes to treat infants and children for diseases or conditions including cerebral palsy and hypoxic ischemic encephalopathy,” the letter says. “Please take immediate action to discontinue any marketing or use of your cellular products or exosomes to diagnose, prevent, treat, mitigate, or cure any disease or condition.”

The company was told to respond within 30 days.

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