Drugs

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

AkivaMed, U.S. (7/23): FDA recently reviewed the company’s Web site (www.akivamed.com) and determined that its “Covid-19 Antibody Rapid Test Kit” marketed to consumers for at-home use is an adulterated and misbranded product. FDA says it has not approved, cleared, or authorized any Covid-19 serology test for at-home testing. To view the letter, click here.

Oxford Medical Instruments USA, Carlsbad, CA (8/11): An FDA review of the company’s Web site determined that its salt inhaler products for treating Covid-19 are misbranded unapproved new drugs. The agency told the company to immediately cease making any claims that its products can prevent, treat, or cure human diseases since there is no reliable scientific evidence, including well-controlled human studies, to support any such claims. To view the letter, click here.

SilveryGuy, Singapore (8/14): FDA says a Web site and Facebook page operated by SilveryGuy is selling unapproved and misbranded colloidal silver representing or implying that the product can mitigate, prevent, treat, diagnose, or cure Covid-19 in people. The agency cites several of the Web site and social media claims that establish the intended use for the product and misleadingly represent it as safe and effective for treating or preventing Covid-19. To view the letter, click here.

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