Drugs

FDA, Others Launch Global Substances System

The FDA Health Informatics Team, the National Institutes of Health Center for Advancing Translational Sciences, and the European Medicines Agency have collaborated to create the Global Substance Registration System (GSRS). An FDA Global Update says the new system will enable the efficient and accurate exchange of information on the substances in a regulated product, giving users the ability to track a product and its different components as it circulates through the supply chain.

The notice says GSRS is groundbreaking because it addresses an unmet need. “Consumers, clinicians, and researchers often have no way of telling which ingredients are contained in commercial products that are domestically and foreign-sourced,” it says. “Certain ingredients are not included in the labeling, and others are labeled ambiguously…. Instead of relying on names, which vary across regulatory domains, countries, and regions, the GSRS knowledge base allows substances to be defined by standardized, scientific descriptions. It classifies substances as chemical, protein, nucleic acid, polymer, structurally diverse, or mixture, as detailed in the International Organization for Standardization’s ISO 11238 and ISO DTS 19844.”

The notice says that by providing a common system with standardized content, GSRS will enable the international monitoring of products and ingredients and help the global community achieve the goal of an accurate substance repository.

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