FDA Policy/General

FDA Sets 4 Strategic Policy Priorities

FDA has released its 2018 Strategic Policy Roadmap that identifies four priority areas to be the focus of additional policy activity in 2018—reducing the burden of addiction crises that are threatening American families; leveraging innovation and competition to improve healthcare, broaden access, and advance public health goals; empowering consumers to make better and more informed decisions about their diets and health and expand the opportunities to use nutrition to reduce morbidity and mortality from disease; and strengthening FDA’s scientific workforce and its tools for efficient risk management.

“While these areas are presented as separate concepts,” the roadmap says, “like much of our work and our mission, the ideas embodied in these priority areas are not independent of each other. There are areas of overlap between these priorities and with other aspects of our work at FDA. Achieving all of these goals will be reciprocally reinforcing, and complement each other aspects of our mission.”

Commenting on the roadmap, FDA commissioner Scott Gotlieb says the specific priority areas were selected “because we believe they embody the overall scope and spirit of our collective efforts as we work together to pursue FDA’s public health mission. Each one of us has an important role to play in achieving this mission…. Our roadmap is not intended to be a traditional strategic plan, and it is not an exhaustive list of the important policies that FDA will initiate and pursue over the coming year. In focusing on these selected efforts, we will optimize our resources to achieve clear deliverables that will yield results over the next two years. Publishing this roadmap is another way that we aim to provide more transparency about FDA’s policy undertakings to all our stakeholders.”

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