Drugs

Pediatric Extrapolation is Expanding: Study

FDA researchers from several disciplines say the use of pediatric extrapolation since 2015 “continues to be expanded and refined. As scientific evidence increases the knowledge and understanding for any given disease and therapeutic response, reevaluation of the optimized use of pediatric extrapolation should be considered during drug development.”

Writing in The Journal of Clinical Pharmacology, the researchers say the study findings provided insight into shifts in the use of pediatric extrapolation approaches to support pediatric drug labeling information. “The international community continues to collaborate on discussion of pediatric extrapolation of efficacy from adults to optimize its use for pediatric drug development,” the article concludes.

The researchers say that the effective and scientifically justified use of pediatric extrapolation has increased the availability of approved drugs for pediatric patients with certain diseases/conditions, but there is still work to be done to optimize the use of pediatric extrapolation.

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