Drugs

FDA Will Update APEC Toolkit: Verbois

CDER Office of Drug Security, Integrity, and Response director Leigh Verbois says the agency will continue to revise and update the APEC (Asia Pacific Economic Cooperation) toolkit to assist in drug supply chain integrity. Interviewed on an Rx 360 podcast, Verbois said that as the toolkit was developed, it became apparent that it needed to involve more than the APEC region because supply chain integrity and security are a worldwide concern. The agency worked with stakeholders from around the world to develop the toolkit, she said.

“The security toolkit contains recommended best practices and tools to prevent, detect, and respond to substandard and falsified medical products before they reach consumers,” Verbois said. “So we’re really making sure that parties that need information have that information at their fingertips.”

Verbois said it’s important to understand that there will be an evolution associated with the toolkit and that it’s something that will address the changing lifecycle of products.

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