Drugs

Coalition for Health AI Meeting Summary

The Coalition for Health AI has released a summary of meetings held by experts across a dozen institutions, with observers from FDA and other stakeholders, working through issues that would need to be addressed for enabling trustworthy artificial intelligence (AI) in healthcare. “This work summarizes those discussions as a step toward a blueprint for implementation guidance on trustworthy AI in healthcare,” the report says. “This blueprint seeks to enable AI that harmonizes standards and reporting for health AI and educate end users on how to evaluate these technologies to drive their adoption. Furthermore, the goal of this blueprint is to enable guidelines regarding an ever-evolving landscape of health AI tools to ensure high-quality care, increase credibility within the community, and meet healthcare needs.”

The working group defined these elements in working toward ethical health AI guidance — bias, equity, fairness, testability, usability, safety, transparency, reliability, and monitoring.

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