Biologics

Company Illegally Marketing ‘Stem Cells’: FDA

An FDA review of the Web site maintained by Mother Stem Institute in Coral Gables, FL, and records it submitted in response to an agency request, established that the firm recovers and processes adipose tissue from donors for autologous use as “stem cells.” An 8/20 Warning Letter says the firm processes adipose tissue into stromal vascular fraction to be administered intravenously to treat a variety of diseases and conditions including Alzheimer’s disease, diabetes, lupus, and rheumatoid arthritis.

The letter notes that the firm’s product is regulated as a biologic that requires an approved BLA or IND, neither of which Mother Stem has. It reminds the company that it is responsible for promptly investigating and determining the causes of any violations, correcting them, and preventing their recurrence, and ensuring full compliance with the law.

“We advise you to comprehensively review your Web site and other labeling and marketing materials to ensure that you are lawfully marketing your products in full compliance with the Federal Food, Drug, and Cosmetic Act, the Public Health Services Act, and their implementing regulations,” FDA says. “Failure to adequately address this matter may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.”

Mother Stem was told to respond with a list of specific actions it has taken to correct violations, with an explanation of and documentation for each action, and a schedule for completing the corrections.

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