Drugs

Court Approves Edge Pharm Injunction

The Vermont federal court has permanently enjoined Edge Pharm, a Colchester, VT, compounding pharmacy, from distributing drugs unless they are manufactured in compliance with the Federal Food, Drug, and Cosmetic Act. A Department of Justice statement says the government alleged that the pharmacy and its owners manufactured and distributed adulterated and misbranded drugs. According to the complaint, they manufactured injectable drugs intended to be sterile under conditions that fell short of the minimum requirements to ensure sterility.

The complaint also says that FDA inspections at the facility between 2014 and 2021 found record-keeping violations, labeling inadequacies, improper airflow, structural disrepair, and the presence in cleanroom suites of mold species that can cause diseases in humans that may be deadly to immunocompromised patients.

The statement says the defendants did not admit or deny the allegations and agreed to settle the suit and be bound by a consent decree of permanent injunction. The decree requires, among other things, that the pharmacy and its owners stop manufacturing and distributing drugs until they take specific remedial measures and demonstrate to FDA that they will comply with federal law

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