FDA Policy/General

FDA FY 21 Budget Initiatives Analyzed

The Alliance for a Stronger FDA says the president’s FY 21 budget request for FDA, the House-passed bill, and the Senate’s new proposed bill have similar funding levels and a common core of initiatives for the agency to carry out in the new fiscal year if, as the Alliance expects, FDA receives about a $40 million increase for FY 21. The Alliance says these six programs are most likely to receive the funding:

artificial intelligence and other emerging technologies (food safety and medical devices);
strengthening response capabilities for foodborne outbreaks;
cannabis and cannabis derivatives;
modernizing influenza vaccines;
transforming medical device safety, cybersecurity, review, and innovation; and
compounding.

The current FY 21 continuing resolution runs through 12/11, the statement says. The Alliance expects that either action on funding bills will be completed by that date, another short-term continuing resolution will be passed to give more time to finish the FY 21 package, or a longer-term continuing resolution will be adopted to move the process to early next year.

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