Biologics

American Medical Aesthetics’ Stem Cell Products

CBER says that American Medical Aesthetics and Regenerative Medicine, Inc., Irvine, CA, markets an unlicensed “stem cell therapy” product that is derived from umbilical cord and may be administered by injection into joints or muscle or infused by IV into blood. A 7/22 Notice of Violation says the company markets its umbilical cord-derived cellular product to patients for diseases or conditions including autism, Duchenne muscular dystrophy, multiple sclerosis, Parkinson’s disease, kidney disease, liver disease, heart disease, lung disease, Hashimoto’s thyroiditis, rheumatoid arthritis, lupus, chronic Lyme disease, and joint repair.

The notice says the company’s cellular product is regulated as both a drug and a biological product and cannot be legally marketed without a valid biologics license.

The agency calls attention to its comprehensive regenerative medicine policy framework for human cell, tissue, or cellular or tissue-based products that it says is intended to spur innovation and efficient access to safe and effective regenerative medicine products.

American Medical Aesthetics 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