FDA Policy/General

$39 Million Boost to FDA Budget in Spending Bill

FDA would see a $39 million boost in its fiscal year (FY) 2017 spending under a budget bill lawmakers unveiled Monday. Under the bill, the agency would receive $2.759 billion in discretionary funding, a little over 1% increase over the FY 2016 enacted level. Total FDA funding, including user fee revenues, is $4.655 billion, which is $103 million above FY2016, which includes an additional $35.6 million to support the implementation of the Food Safety Modernization Act, and $10.9 million is provided to supplement medical product safety and the Precision Medicine initiatives authorized in the 21st Century Cures Act. In addition, $10 million is provided for FDA to respond to emerging health threats, including Ebola and Zika viruses. The House is expected to vote on the measure 5/3.

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