Biologics

Sparrow Health Selling Unapproved Cell Products: CBER

The CBER Office of Compliance and Biologics Quality says Sparrow Health & Performance, Hoover, AL, has been offering on a Web site and Facebook page cellular products derived from adipose tissue as “stem cell therapy” to treat many diseases or conditions. A 5/11 notice of violation says that more recently the company offered its adipose tissue-derived cellular products to mitigate, prevent, treat, or cure Covid-19.

The letter says that since it appears that Sparrow does not qualify for any regulatory exception and that its products are intended for nonhomologous uses, the products are regulated as drugs and biologics and require a valid BLA or IND, neither of which Sparrow currently has.

“Your adipose tissue-derived cellular products are intended to treat a variety of serious or life-threatening diseases or conditions,” the letter says. “Such unapproved uses raise potential significant safety concerns. Moreover, because your products appear to be administered by various higher-risk routes of administration, their use, if contaminated, could cause a range of adverse events.”

CBER also noted that the firm’s Web site lists exosomes as one of its services. “As a general matter,” it says, “exosomes for clinical use in humans are also regulated as drugs and biologics … and are subject to premarket review and approval requirements….”

The letter reminds the firm of its responsibility to ensure that all its products fully comply with the Federal Food, Drug, and Cosmetic Act and the Public Health Services Act and tells the company to respond within 30 days.

Gupta Raises Concerns About Overton’s Independence, Ideology

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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