Drugs

Guardian Pharmacy Services Consent Decree

A Texas federal judge has entered a consent decree ordering Guardian Pharmacy Services, a Dallas drug compounder, to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements. An FDA news release says that despite receiving agency warnings, Guardian continued to violate the law, putting patients at risk.

The government says the company manufactured and distributed purportedly sterile drug products that were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements. The complaint also says that Guardian drugs were misbranded because they did not include adequate directions for patient use. Also, it says, some of the drug labels were false or misleading.

The consent decree requires Guardian to cease sterile operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure it is complying with the law. Guardian may not resume sterile compounding operations until it establishes and implements, among other things, a comprehensive quality control system and receives authorization from FDA.

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