Drugs

Researchers Confirm Increasing AI/ML Role in Drug Development

CDER researchers say their landscape analysis of the application of artificial intelligence (AI) and machine learning (ML) in drug regulatory submissions from 2016 to 2021 confirms an earlier prediction that AI/ML would play an increasingly important role in drug development. Writing in Clinical Pharmacology & Therapeutics, the authors say AI/ML was used to perform a variety of tasks such as informing drug discovery/repurposing, enhancing clinical trial design elements, dose optimization, enhancing adherence to a drug regimen, endpoint/biomarker assessment, and postmarketing surveillance.

The researchers say the trend toward AI/ML applications for drug development is only likely to increase over time. “Both opportunities and challenges lie ahead for the potential uses of AI/ML,” they conclude, “and pharmaceutical and technology companies are actively investing in this area. Moreover, academic researchers are continuing to investigate current and future applications. FDA has also been preparing to manage and evaluate AI/ML uses by engaging with a broad set of stakeholders on these issues and building its capacity in these scientific fields.”

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

Read more

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