Drugs

FDA Doing Better On Sex, Gender Differences in Drug Development: Study

Nine FDAers led by FDA Office of Women’s Health director of scientific programs Marjorie Jenkins say the agency “has made measurable progress incorporating consideration of sex and gender differences into drug trial development and FDA consideration of these data, supporting inclusion of women in clinical trials, providing a comprehensive drug safety review, and advancing postmarket surveillance and risk assessment, thus strengthening FDA’s ability to protect public health.” Writing in the Journal of Women’s Health, the authors examine drugs withdrawn from the market for safety-related reasons from 1/1/2001 to 1/1/2018.

“This review … highlights several important issues, particularly the complexity of determining whether certain adverse drug events occur more often in specific demographic groups,” the article says. “FDA works continuously to ensure the safety of all currently marketed drug products and has demonstrated that action will be taken when findings suggest a safety signal. FDA conducts rigorous safety and efficacy reviews of drugs considered for approval, weighing benefit versus risk, to fulfill the mission of protecting the health of the public. As science, technology, and data resources evolve, so too will FDA’s ability to evaluate drug safety and effectiveness.”

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