Devices

FDA Says Vivera Selling Adulterated, Misbranded Covid Tests

FDA says its review of Web sites maintained by Vivera Pharmaceuticals, Mission Viejo, CA, determined that the firm is marketing Covid-19 antigen test kits in the U.S. A just-released 7/26 Warning Letter says the tests are offered for sale without marketing approval, clearance, or authorization from FDA and thus are adulterated. The tests also are misbranded, it says, because Vivera did not notify FDA of its intent to introduce the devices into commercial distribution.

“We advise you to review your Web sites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and/or effective for a Covid-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that adulterate or misbrand the products in violation of the Federal Food, Drug, and Cosmetic Act,” the letter says.

Vivera was told to respond by e-mail with a list of specific steps it has taken to prevent the recurrence of these violations and copies of related documentation.

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