Drugs

FDA Seeks End to Dog Use in Clinical Trials

FDA is seeking to eliminate the use of dogs in clinical research by animal drug developers. The agency says it will propose a study that, once completed, could help establish a non-animal based model that will “potentially replace much of the need to use dogs in future trials with new informatics tools. In short, our goal is to do one single study involving a small number of dogs — where the dogs will only be subject to minimally invasive blood sampling, and adopted as pets at the completion of the short trial — to eliminate the need for the use of dogs in certain types of future studies, some where they might have been euthanized.”

The proposed study is part of FDA’s recent efforts to reduce reliance on animals used in research. The study goal is to validate a research model for comparing blood levels of certain orally-administered canine drugs in order to provide an alternative approach that animal drug developers can use to generate data to support FDA product approval. The agency is accepting public comment on a white paper outlining this proposed study for the next 60 days.

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