FDA Policy/General

Comprehensive Approach to Nicotine and Tobacco

FDA commissioner Scott Gottlieb says the agency is taking a new approach to tobacco and nicotine through an initiative to lower nicotine in cigarettes and find new ways to support development and regulation of nicotine replacement therapy (NRT) products that help smokers quit. In an online post with CDER director Janet Woodcock and Center for Tobacco Products director Michael Zeller, Gottlieb says that a new Nicotine Steering Committee will consider the types of safety and efficacy studies required for NRT products and the way the products are used and labeled.

“The aim is to make sure FDA has the right policies in place to enable the development of product innovations that have the potential to be more helpful in helping smokers quit combustible cigarettes and maintain abstinence,” the post says. “This could include changes to the labeling and indications for existing products or a new product that might deliver nicotine at different rates, or through different delivery mechanisms entirely. To enable innovation, FDA might contemplate additional approaches to developing these products, including new clinical trial endpoints.”

As one of its new steps, the new steering committee will hold a 1/26/18 public hearing on FDA’s Approach to Evaluating Nicotine Replacement Therapies. The post says the agency believes it is critical to obtain input from the public on how evolving science could influence the agency’s approach to evaluating the safety and effectiveness of NRT products.

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