Drugs

Fusion Health Sold Unapproved Covid Products: FDA

FDA says Web sites operated by Fusion Health and Vitality, Alpharetta, GA, sold products intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 5/11 Warning Letter says the firm’s products were unapproved new drugs that were also misbranded.

The letter says that as of 5/11 the company no longer appears to be marketing one of the cited products and the claims for the other product appear to have been removed. “Due to the serious public health concerns related to the marketing and sale of unapproved drugs for the mitigation, prevention, treatment, diagnosis, or cure of Covid-19, it is essential that these violations do not recur,” the notice says.

Fusion was told to examine its Web sites, product labels, and other labeling and promotional materials to ensure that it is not misleadingly representing its products as safe and effective for a Covid-19-related use for which they have not been approved by FDA and that Fusion does not make claims that misbrand the products. It was told to e-mail the agency describing the specific steps it has taken to prevent the recurrence of future violations.

FDA also wrote it is adding Fusion to its published list of firms and Web sites that have been warned about the sale or distribution of Covid-19 related products in violation of the Federal Food, Drug, and Cosmetic Act, with a note that its products are no longer sold for the mitigation, prevention, treatment, diagnosis, or cure of Covid-19.

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