Drugs

FDA Floats AI Modeling to Help Assess Drug Safety

FDA has announced a new drug safety initiative that aims to develop artificial intelligence (AI) models for toxicological endpoints that are key to assessing drug safety and may help evaluate drug candidates before they are tested in human trials. Called SafetAI, the initiative involves FDA’s National Center for Toxicological Research and its development of a “suite of deep learning-based QSAR [quantitative structure-activity relationship] models for various safety endpoints critical to regulatory science and the IND review,” the agency says. “Currently, the initiative has focused on five key safety endpoints: hepatotoxicity, carcinogenicity, mutagenicity, nephrotoxicity, and cardiotoxicity.”

FDA says that under the plan, it is developing a “deep learning framework which is designed to optimize toxicity prediction for individual chemicals based on their chemical characteristics. The method was compared to several conventional machine learning and state-of-art deep learning methods for predicting drug-induced liver injury (i.e., DeepDILI), carcinogenicity (i.e., DeepCarc), and Ames mutagenicity (i.e., DeepAmes). The preliminary results from this method yielded significant improvement in these toxicity endpoints in comparison to other deep learning and QSAR methods.”

Previously, FDA has recognized that QSAR models are an “increasingly important part of regulatory review because they can provide rapid assessment of the toxicological and pharmacological properties of a compound based solely on its chemical structure. QSAR modeling is a well-known technique that reveals associations between structural characteristics or properties and biological or toxicological activities under the general assumption that similar chemical structures display similar activities. Predictions can be generated for a drug substance itself, intermediates, pre-cursor materials related to the drug substance, degradation products, or leachables.”

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