FDA Policy/General

Hims & Hers Super Bowl Ad Hit

The Institute for Safe Medicines says FDA, the Federal Trade Commission, and the Department of Justice should take immediate action against Hims & Hers for its Super Bowl ad that promoted unapproved compounded drug products. A 3/3 letter to FDA says the ad “contained a startling array of unsubstantiated and misleading claims.”

The letter says Hims & Hers is a repeat violator, noting that as recently as 9/9/2025, FDA issued two Warning Letters to the company for false or misleading promotion of compounded drug products.

“FDA and the Federal Trade Commission should take immediate enforcement to protect the public health and respond to this brazen conduct,” the institute writes. “The Department of Justice should consider action such as seeking an injunction, product seizure, prosecutions, and civil and criminal penalties….”

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