Devices

Anne’s Daye Pulls CBD Tampons in U.S.

The UK-based maker of Anne’s Daye Tampons says it is pulling its CBD-coated tampons intended to relieve menstrual pain from the U.S. market following receipt of an FDA Warning Letter. The letter said the adulterated products were not approved for sale in the U.S. and were misbranded due to the addition of cannabinoids.

An online Marijuana Moment post says FDA indicated the company had not notified the agency of changes and modifications to the tampons that could significantly affect their safety or efficacy.

“In light of this feedback and given the sensitive regulatory landscape surrounding cannabinoids in medical devices within the U.S.,” the company told the newsletter, “we have made the decision to voluntarily remove the CBD Daye Tampons from the U.S. market while we evaluate alternative pathways to regulatory compliance. We are actively working with FDA to address their concerns and clarify any misunderstandings about our products’ regulatory status.” FDA declined to comment on an open compliance matter to Marijuana Moment.

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