FDA Policy/General

Machine Learning Increasingly Important to FDA

Eight FDA staffers say they envision that machine learning will play an increasingly important role in future drug development and regulation. Writing in Clinical Pharmacology and Therapeutics, they say (membership or purchase required) that machine learning “will likely be an essential tool for data aggregation, information synthesis, pattern recognition, and decision optimization. Regulatory agencies will likely receive more submissions using machine learning components, and machine learning will undoubtedly play an important role in facilitating regulatory review and research as well as optimizing operations.”

The authors write that in general, the utilization of machine learning tools should be fit-for-purpose and risk-based. Proper validation of machine learning algorithms is critical to ensure their performance, they say.

The article includes background information on machine learning, examples of machine learning submissions to FDA, and examples of machine learning applications in the agency’s review and research.

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