Drugs

Court Order Against Salud Natural Entrepreneur

An Illinois federal court has ordered Salud Natural Entrepreneur, Waukegan, IL, to stop distributing dietary supplements that violate the Federal Food, Drug, and Cosmetic Act (FFDCA). A Department of Justice statement says the company and its owner, production manager, and quality control manager violated the FFDCA by distributing adulterated and misbranded dietary supplements and unapproved new drugs that the company claimed would cure, mitigate, treat, or prevent diseases such as cancer, hypertension, and heart disease.

The department says the company did not comply with good manufacturing practice regulations designed to help ensure the safety of dietary supplements. It says that on one occasion Salud used ingredients that had tested positive for salmonella in manufacturing a product.

The defendants agreed to settle the suit and be bound by the consent decree of permanent injunction that requires, among other things, that the defendants stop manufacturing, processing, labeling, holding, or distributing any product that they claim can treat or cure disease until they comply with federal law, the statement says. The defendants also must bring their operations into compliance with current good manufacturing regulations.

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