Drugs

FDA Warns Clinics on Unapproved Covid ‘Cures’

Three FDA Centers and the Federal Trade Commission say that Web sites and YouTube channels operated by Create Wellness Clinics (21^st Century LaserMed Pain Institute), Garden Grove, CA, are offering products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 7/21 Warning Letter addresses issues involving the firm’s umbilical cord stem cell product, exosome product, immune support bundle and immune boost protection kit products, and Covid-19 test kit product.

The firm was told to take immediate action to correct the violations and to respond by e-mail describing the specific steps it has taken to correct the violations and prevent their recurrence with copies of related documentation and a schedule for completing the actions.

The products are being placed on FDA’s list of products that don’t comply with agency requirements are being misleadingly represented as safe and/or effective for treating or preventing Covid-19. The letter says they will be removed from the list when Create Wellness has taken corrective actions to stop the sale of its unlicensed, unapproved, uncleared, and unauthorized products for the mitigation, preventing, treatment, diagnosis, or cure of Covid-19 and the actions have been confirmed by FDA.

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