Drugs

Final Guidance on Recall Notification

FDA has issued a final guidance outlining circumstances when a company should issue a public warning about a voluntary recall, describing the general timeframe for companies to issue such a warning, discussing what information should be included in a public warning, and describing situations where FDA may take action to issue its own public warning should a company’s warning be deemed insufficient. The document also describes the agency’s policy for moving forward with posting recalls to its online resource of all recalls monitored by FDA, in some cases before a final health hazard evaluation is completed.

In a statement on the final guidance, FDA commissioner Scott Gottlieb said the agency has begun implementing the recommendations outlined in the final guidance. He reviewed other steps taken by the agency leading to finalization of the guidance.

“Our ability to detect, track, and trace potential or known problems with products continues to improve as we implement new technologies across the agency and as companies implement their own technological advances throughout their supply chains,” Gottlieb said. “Consumers should expect to continue to see more frequent communication on potential risks to their health. We’ll continue to seek out opportunities for improved processes, education, and awareness. And we constantly strive to learn from every recall, and every issue, so that we can help to prevent future recalls and to work quickly with companies to remove the products from the market.”

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