Drugs

Permanent Injunction Against Dietary Supplement Company

A New York federal judge has entered an order of permanent injunction sought by FDA against Confidence USA, a Long Island, NY, dietary supplement manufacturer, and the company’s president, Helen Chian, and general manager, Jim Chao. The injunction requires that the company and the two executives stop manufacturing, holding, or distributing any articles of food, including dietary supplements, until they comply with federal dietary supplement current good manufacturing practice regulations and other Federal Food, Drug, and Cosmetic Act requirements, according to an FDA statement.

The statement says Confidence USA has manufactured and distributed more than 50 dietary supplements under several brand names. It currently manufactures and distributes the supplements through Amazon, Walmart, and its online store, FDA says.

According to the statement, multiple FDA inspections showed that the defendants repeatedly failed to verify the identity of each dietary ingredient used in the manufacture of their supplements. They also reportedly failed to verify that their products met specifications for purity, strength, composition, and contamination limits.

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

Read more

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