Drugs

More Supplements Risk Oversight Coming: Califf

FDA commissioner Robert Califf says the Office of Dietary Supplement Programs (OSDP) will be reporting to the Office of Food Chemical Safety, Dietary Supplements, and Innovation in the agency’s new Human Foods Program that is being developed. In an online blog post, Califf says the new structure “is designed to ensure that the dietary supplement program remains a critical priority for the agency.” He says there are no current plans to reduce OSDP’s resources or capabilities and it will remain the lead office responsible for executing FDA’s responsibilities under the Dietary Supplement Health and Education Act.

Califf writes that a unified human food program will facilitate a stronger and more effective risk-management framework across the entire foods portfolio and ensure resources are shared and coordinated across the program and the Office of Regulatory Affairs. He says the ODSP will be charged with ensuring that risks related to dietary supplements are elevated and managed using the appropriate oversight tools.

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