Drugs

Dynamic Stem Cell Marketing Unapproved Biologics

The CBER Office of Compliance and Biologics Quality says Dynamic Stem Cell Therapy, Henderson, NV, is marketing cellular products derived from adipose tissue and human umbilical cord as a treatment for many diseases and conditions, including Covid-19. A 4/1 letter says the products are regulated as drugs and that it is illegal to market them without a biologics license.

“Your adipose-derived cellular product and human umbilical cord-derived cellular product are intended to treat a variety of diseases or conditions, including some that are serious or life-threatening,” CBER writes. “Such unapproved uses raise potential significant safety concerns. Moreover, because at least some of your products are administered by a higher risk route of administration their use, if contaminated, could cause a range of adverse events.”

The letter also notes that the company’s Facebook page references exosomes and says that generally exosomes for clinical use in humans are also regulated as drugs and biological products.

“You and your firm are responsible for ensuring that all your products fully comply with the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act,” FDA concludes.

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