FDA Policy/General

Group Urges $200 Million Boost in FDA Funding

The Alliance for a Stronger FDA is urging Congress to provide FDA with $3.9 billion in budget authority (excludes user fee funding) for salaries and expenses for fiscal year (FY) 2025, which is more than $200 million (5%) above President Biden’s recent budget request (see earlier story) and $377 million (8%) more than the current FY 2024 funding level.

In a letter to House and Senate appropriators, the Alliance said: “We understand that overall discretionary spending limits will force difficult and uncomfortable decisions. We also know that America’s health, safety, and capacity to innovate is directly tied to the Food and Drug Administration. We encourage your support of all of FDA’s funding needs.”

An Alliance release notes that “FDA’s mission continues to expand and its activities are more and more complex, requiring greater and costlier sophistication and expertise.

"The cutbacks in FY 24 funding are unfortunate,” the group continues. “A second year without increased funding will challenge FDA’s ability to meet its responsibilities using best-trained scientists and the most effective tools and technologies.”

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