FDA Policy/General

Trump Orders FDA, Others to Form Reform Task Force

President Trump 2/24 signed an executive order requiring FDA and other federal agencies to “establish a regulatory reform task force, which will ensure that every agency has a team of dedicated — and a real team of dedicated people — to research all regulations that are unnecessary, burdensome and harmful to the economy, and therefore harmful to the creation of jobs and business.” Surrounded by business leaders in the Oval Office, including Merck CEO Ken Frazier, and Johnson & Johnson CEO Alex Gorsky, Trump said each task force will make recommendations to repeal or simplify existing regulations. “The regulatory burden is for the people behind me and for the great companies of this country, and for small companies — an impossible situation, we’re going to solve it very quickly,” he said. “They will also have to really report every once in a while to us so we can report on the progress, and so we can come up with some even better solutions.”

Trump declared that “every regulation should have to pass a simple test: Does it make life better or safer for American workers or consumers? If the answer is no, we will be getting rid of it and getting rid of it quickly. We will stop punishing companies for doing business in the United States. It’s going to be absolutely just the opposite. They’re going to be incentivized for doing business in the United States.”

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