Drugs

AI/ML Challenges in Precision Medicine: FDA Paper

Researchers from FDA, PharmaLex, and Quinten Health say there remain challenges to address before artificial intelligence/machine learning (AI/ML) has an increased impact on precision medicine. Writing in Therapeutic Innovation & Regulatory Science, the researchers summarize the topics discussed at a 2022 panel of FDA and industry experts about the challenges of successfully applying AI/ML to precision medicine.

“Bias is an important issue,” they say, “such as selection bias where data are not representative of the target population…. It is important to adopt strategies during early planning to mitigate these biases.”

The paper says that when selecting data to train and validate AI/ML tools, it is important to employ methods and systems that ensure sufficient data quality. In addition, it says, the demonstration of external validity is desired for improving the generalizability of performance of AI/ML algorithms when applied to patients and settings different from those on which the development or training was performed.

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