Drugs

Stop Selling Illegal Opioids, FDA Warns Online Nets

FDA has warned nine online networks that operate a total of 53 Web sites to stop illegally marketing potentially dangerous unapproved and misbranded versions of opioid medications, including tramadol and oxycodone. An agency news release says that Warning Letters went to these networks: AnonShop. Eassybuyonline, Instabill ECS-Rx, Medstore.biz, One Stop Pharma, RemedyMart, RxCash.biz, TramadolHub, and XLPharmacy. Companies that fail to correct the violations may be subject to enforcement action, including product seizure or injunction, the release says.

CDER Office of Compliance director Donald Ashley says the public “needs to know that no one is authorized to sell or distribute opioids via the Internet in the U.S., with or without a prescription. Drug dealers and rogue Web site operators are using the Internet to fuel the opioid crisis, heartlessly targeting millions of Americans struggling with opioid use disorder. We will continue to aggressively pursue these criminals and take swift action to protect the American public.”

The companies were told to respond with a list of specific steps taken to correct the violations and prevent their recurrence.

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