FDA Policy/General

FDA Launches Elsa AI Tool for Efficiencies

FDA 6/2 launched a generative Artificial Intelligence (AI) tool called Elsa that is designed to help employees — from scientific reviewers to investigators — work more efficiently. The agency is already using Elsa to accelerate clinical protocol reviews, shorten scientific evaluations, and identify high-priority inspection targets.

The tool is built into a “high-security GovCloud environment” that offers a secure platform for FDA employees to access internal documents while ensuring all information and data remains within the agency, an FDA notice says. “The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff.”

“As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency,” FDA chief AI officer Jeremy Walsh is quoted in the notice as saying.

Elsa is described as “large language model–powered AI tool designed to assist with reading, writing, and summarizing. It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.”

Elsa is the first step in FDA’s AI initiative. “As the tool matures, the agency has plans to integrate more AI in different processes, such as data processing and generative-AI functions to further support the FDA’s mission,” the notice says.

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