FDA Policy/General

Senate Appropriators Announce 4/19 FDA Budget Hearing

The Senate Appropriations Committee has announced a 4/19 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee hearing to review FDA’s fiscal year 2024 budget request. While it is still too early for witnesses to be announced, typically FDA commissioner Robert Califf would be the primary official requested for his testimony.

Last week, FDA released its proposed budget request seeking a $372 million (10%) boost and a $150 million increase in user fees (see earlier story). The total funding being proposed for FDA, including $3.5 billion in total user fees, is $7.2 billion. More than a quarter of the proposed increase, $98 million, would fund efforts to strengthen medical product safety and availability across FDA’s medical product Centers. “The budget includes funding to evaluate the performance, safety, and effectiveness of medical products, support resilience in the medical supply chain for devices, and funding to support public health programs to combat the opioid epidemic,” according to the agency’s budget document.

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