Drugs

Condemned Labz Selling Illegal New Drugs: FDA

FDA says its review of a Web site and social media pages maintained by Supplement Science Corp., doing business as Condemned Labz, Brooklyn, NY, found significant violations of the Federal Food, Drug, and Cosmetic Act, including selling misbranded unapproved new drugs. A 9/22 Warning Letter lists claims the company makes for its products that establish that they are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

The letter says the unapproved drugs also are misbranded because they do not contain adequate directions for use.

Two of the firm’s products are labeled as dietary supplements, FDA says, and even if they did not have therapeutic claims that make them misbranded unapproved new drugs, they would be adulterated dietary supplements.

Condemned Labz was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with copies of related documentation and a schedule for completing the corrective actions.

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