FDA Policy/General

‘MAHA Summit’ to Hear from Vance, Kennedy, Makary

An 11/19 MAHA Summit in Washington will bring together leaders and influencers of the Make America Health Again movement, according to an event schedule obtained by Politico. An online post says the gathering will hear from vice president JD Vance and HHS secretary Robert F. Kennedy, Jr. The summit is reported to be closed to the news media.

“The blockbuster event shows the convening power of Kennedy’s MAHA movement,” Politico says. “Its leaders have emphasized MAHA’s role in president Donald Trump’s victory last year and advised GOP politicians gearing up for next year’s midterm elections that they should embrace MAHA if they want to win.”

The post lists many of the presentations and panels scheduled for the summit, including one by FDA commissioner Marty Makary on “FDA of the Future.”

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