Drugs

Info Request Period on AI Use in Early Trials Extended

FDA is extending by 30 days the comment period on a request for information entitled “AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program." Earlier this year, the agency announced it was seeking comments on how AI-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials. Comments now can be submitted by 6/29.

The pilot is intended to target a longstanding bottleneck in drug development: early-phase trials, which are often marked by small patient populations, fragmented data flows and slow decision-making, according to the agency. Historically, trial data has moved from clinical sites to sponsors for analysis before being submitted to FDA, a process that can take months or years.

The agency’s longer-term goal is to enable continuous clinical development, reducing or eliminating the pauses that typically occur between trial phases. By allowing regulators to monitor data in real time, the agency believes transitions between phases could be streamlined, potentially speeding up product approvals.

The information request seeks feedback on how to design and evaluate the planned pilot program, including metrics for success. The pilot will also explore how advances in AI and data science can enhance safety monitoring, facilitate dose selection decisions, and enable more informed early go/no-go decisions (e.g., a regulatory decision as to whether a Phase 1 study may proceed). The pilot will be guided by principles aligned with the National Institute of Standards and Technology AI Risk Management Framework, the agency says.

Earlier, FDA projected the pilot’s final selection criteria to be available in July and pilot participants chosen by August.

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