Drugs

Iotech Selling Illegal Covid-19 New Drugs: FDA

FDA says its reviews of a Web site and social media sites maintained by Iotech International, Boca Raton, FL, determined that the company is selling ioRinse and ioCleanse in the U.S., saying they are intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 3/15 Warning Letter says the agency considers the products to be unapproved new drugs that also are misbranded.

The letter reviews claims for the products that establish that they are legally considered to be unapproved new drugs. It says the Iotech products do not conform to the applicable tentative final monograph or any other rule or monograph that would allow them to be marketed without an approved application.

The firm was told to take immediate action to address the letter’s violations and was told to respond in an e-mail describing the specific steps it has taken to address the violations, with an explanation of each step being taken to prevent the recurrence of any violation and copies of related documentation. “Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction,” FDA says.

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