Drugs

FDA Seeks BEST Resource Taxonomy Comments

FDA has established a docket to receive comments for 60 days on its publication of a glossary of terms that is part of the BEST (Biomarkers, Endpoints, and Other Tools) Resource Taxonomy. A Federal Register notice says FDA developed a Web page describing the BEST resource taxonomy and links to the office National Library of Medicine Web page for the BEST glossary of terms.

“Comments on the BEST resource taxonomy will help FDA enhance its utility and may assist FDA in developing future versions of this resource and identifying best methods for conveying information about biomarkers, endpoints, and other drug development tools to the general public,” the notice says.

Updates to the BEST resource on the National Library of Medicine Web site, the notice says, are FDA’s response to a 21^st Century Cures Act requirement that the agency collaborate with biomedical research consortia and other interested parties to “establish a taxonomy for the classification of biomarkers (and related scientific concepts) for use in drug development.”

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