Drugs

Stimulant Use Disorder Treatment Guidance

FDA has published a draft guidance, Stimulant Use Disorders: Developing Drugs for Treatment, to assist sponsors in developing such treatments. An agency online notice (contains a link to the guidance) says that when it is finalized, the document will be the first to provide FDA’s current thinking on the overall program and clinical trial design to develop drugs and biologics to support the treatment of moderate to severe cocaine use disorder, methamphetamine use disorder, and prescription stimulant use disorder.

The draft has recommendations about clinical trial design related to evaluating stimulant use disorder treatments. “Designing clinical studies to evaluate the safety and effectiveness of stimulant use disorder treatments presents a number of unique challenges, from selecting appropriate populations for studies to determining the most appropriate clinical endpoints, that require careful review,” the notice says. “However, there are opportunities to improve clinical trial design and develop trials that are more person-centered, which may result in increased sensitivity to detect a treatment effect, with the potential for treatment effects to be linked to meaningful long-term outcomes.”

The guidance also describes basic considerations throughout the drug development process including trial conduct, data collection, methods to assess treatment response, subject safety, and new drug application requirements.

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