FDA Policy/General

Variability in Sex-Based Drug Difference Info

University of Maryland School of Pharmacy researchers say there is substantial variability in the information on sex-based differences in drug safety and efficacy across trial publications and FDA sources for medications that were approved in 2019 and 2020. Healios reports the study, which was published in the Journal of General Internal Medicine, also found that the sources excluded information on sex-based dosing recommendations for drugs with reported sex differences. Moreover, it says, women were frequently underrepresented in the trial cohorts that FDA used to approve the drugs.

“To support informed treatment decisions, healthcare professionals rely on different sources of medical evidence such as trial publications, drug labels, and other FDA sources,” lead researcher Kyungwan Hong told Healio. “The information on potential sex-based differences should be consistent across sources and easily accessible. When important information is missing about potential sex-based differences, this may inhibit informed treatment decisions and optimized patient care.”

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