Drugs

Roadmap to Reduce Drug Safety Animal Testing

FDA was one of 16 federal agencies that developed a “strategic roadmap” with a new framework for safety testing of drugs and chemicals that will provide more human-relevant toxicology data while reducing the use of animals. The National Toxicology Program published the roadmap 1/30.

The agencies say the roadmap was developed to guide application of new technologies, such as high-throughput screening, tissue chips, and computational models, to toxicity testing of chemicals and medical products. Three strategic goals identified as being needed for progress are:

connecting new test method developers with end users;
promoting flexible approaches for establishing confidence in new methods; and
encouraging adoption of new methods by federal agencies and regulated industries once validated.

Objectives described in the roadmap identify activities that should be undertaken by regulatory agencies, test method developers, regulated industries, funding agencies, and other stakeholders to achieve the stated goals.

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