Drugs

FDA Exploring CBD Regulatory Paths

FDA commissioner Stephen Hahn says the agency is evaluating potential regulatory pathways outside of the existing drug pathway that would allow various types of CBD products to be lawfully marketed. In a 2/26 presentation to the National Association of State Departments of Agriculture, Hahn said the agency wants to “empower the American consumer with accurate information about CBD and the role that FDA plays.”

He said that as the evaluation of potential regulatory pathways continues, FDA will remain focused on the many unanswered questions concerning the safety of CBD in unapproved medical products, consumer products, and foods. “For instance,” he said, “there’s still much we don’t know about the effects of sustained, long-term exposure to these products. I can assure you that FDA will move forward carefully and deliberately as we determine the appropriate path to take.”

He said the agency’s approach to this and all other questions will involve reliance on the best available science.

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