Drugs

Court Orders Sundial Herbal to Stop Distribution

A Southern New York federal judge has ordered Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs until it complies with federal law. According to the complaint, despite previous warnings from FDA and repeated promises to correct violations, Sundial continued to distribute its products. “The court concluded that Sundial's products have no published adequate and well-controlled studies to support their claims, and the FDA has not approved any application for any of Sundial's drugs, despite Sundial claiming that their products can cure, treat, or prevent a wide variety of diseases, including syphilis, cancer, and HIV/AIDS,” an FDA release says.

The court action follows multiple FDA inspections conducted at Sundial between 2012 and 2017. The agency also sent a Warning Letter to the company in 2013 for similar violations. “Despite assurances that the violations noted in the Warning Letter would be corrected, follow-up inspections revealed that the defendants did not make the necessary corrections,” the agency says.

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