Drugs

Jordan’s Crossing Selling Unapproved, Misbranded Covid Products: FDA

The CDER Office of Compliance says a review of the Web site and social media sites maintained by Jordan’s Crossing Herbal Connections, Barnsdall, OK, determined that the company is offering its “Germaphobe’s Delight Spray” to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 7/20 Warning Letter says the product is considered to be an unapproved new drug that also is misbranded.

The letter includes some of the claims made for the product and says Jordan’s Crossing should take immediate action to address the violations. “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 effective for a Covid-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the Federal Food, Drug, and Cosmetic Act,” the letter says.

The company was given 48 hours to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation for each step. Failure to correct any violation could result in legal action, the letter warns.

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