FDA and OpenAI Explore AI Integration for Accelerating Drug Evaluations
8 Sources
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OpenAI and the FDA are reportedly discussing AI for drug evaluations
OpenAI has met with officials from the U.S. Food and Drug Administration to discuss the agency's use of AI to speed up drug evaluations, Wired reported on Wednesday. According to the report, OpenAI and the FDA have discussed a project called cderGPT, which seems to be an AI tool for the Center for
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OpenAI and the FDA Are Holding Talks About Using AI In Drug Evaluation
High-ranking OpenAI employees have met with the FDA multiple times in recent weeks to discuss AI and a project called cderGPT. The Food and Drug Administration (FDA) has been meeting with OpenAI to discuss the agency's use of AI, according to sources with knowledge of the meetings. The meetings
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OpenAI and US FDA hold talks about using AI in drug evaluation, Wired reports
May 7 (Reuters) - OpenAI and the U.S. Food and Drug Administration have been meeting to discuss the health regulator's use of AI, technology news platform Wired reported on Wednesday, citing sources with knowledge of the meetings. Sources close to the project say a small team from OpenAI has met
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FDA's plan to roll out AI agencywide raises questions
Why it matters: The plan raises urgent questions about what's being done to secure the vast amount of proprietary company data that's part of the process and whether sufficient guardrails are in place. Driving the news: The FDA is racing to roll out generative AI across all its centers to augment
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The FDA Will Use AI to Accelerate Approving Drugs
The Food and Drug Administration just announced that it will immediately start using AI across all of its centers, after completing a new generative AI pilot for scientific reviewers. Supposedly, the AI tool will speed up the FDA's drug review process by reducing the time its scientists have to
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OpenAI and xAI talking AI drug evaluation with FDA
OpenAI has met with officials from the U.S. Food and Drug Administration (FDA) to discuss using AI to speed up drug evaluations, according to a report by Wired. The discussions centered around a project called cderGPT, an AI tool designed for the Center for Drug Evaluation (CDE), which regulates
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FDA Explores AI for Drug Approvals, Faces Oversight Questions
The US Food and Drug Administration (FDA) is exploring how artificial intelligence could accelerate drug approvals. A recent WIRED report revealed that the agency met multiple times with OpenAI to discuss this possibility, including a project referred to as cderGPT, a likely reference to the Center
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OpenAI and US FDA hold talks about using AI in drug evaluation, Wired reports
(Reuters) -OpenAI and the U.S. Food and Drug Administration have been meeting to discuss the health regulator's use of AI, technology news platform Wired reported on Wednesday, citing sources with knowledge of the meetings. Sources close to the project say a small team from OpenAI has met with the
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The FDA is in talks with OpenAI to implement AI in drug evaluation processes, aiming to speed up approvals. This move raises questions about data security and the reliability of AI in critical healthcare decisions.
FDA and OpenAI Collaborate on AI-Assisted Drug Evaluations
The U.S. Food and Drug Administration (FDA) is reportedly in discussions with OpenAI to integrate artificial intelligence into its drug evaluation processes. This collaboration aims to accelerate the notoriously lengthy drug approval timeline, which can often exceed a decade
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.Project cderGPT and Key Players
At the center of these talks is a project called cderGPT, likely referring to an AI tool for the Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription drugs in the U.S.
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. The discussions have involved a small team from OpenAI, FDA officials, and associates from Elon Musk's Department of Government Efficiency2
.Jeremy Walsh, the FDA's first-ever AI officer, has been leading these discussions. Additionally, Peter Bowman-Davis, an undergraduate student on leave from Yale serving as the acting chief AI officer at the Department of Health and Human Services, has been involved in conversations about the FDA's AI ambitions
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.Potential Benefits and Timeline
FDA Commissioner Marty Makary has expressed enthusiasm for modernizing the drug approval process with AI, stating that the agency has already completed its first AI-assisted scientific review for a product
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. The FDA aims to achieve full AI integration across all its centers by June 30, an ambitious timeline that has raised some concerns5
.Concerns and Challenges
While the integration of AI in drug evaluation processes holds promise, it also raises several questions:
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Data Security: There are concerns about securing the vast amount of proprietary company data involved in the drug approval process
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AI Reliability: Given the critical nature of drug approvals, the potential for AI hallucinations and errors is a significant concern
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Training Data: Questions remain about which models are being used to train the AI and what inputs are being provided for specialized fine-tuning
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Regulatory Framework: There is a need for policy guidance on acceptable AI model performance and the types of data used for training
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Broader Context of AI in Government
The FDA's AI initiative is part of a larger trend of AI adoption in federal agencies during the Trump administration. This includes OpenAI's ChatGPT Gov, designed to process sensitive government information, and efforts to use AI in other departments such as the General Services Administration and Social Security
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.Expert Opinions
Rafael Rosengarten, CEO of Genialis and a board member of the Alliance for AI in Healthcare, supports automating certain tasks in the drug review process but emphasizes the need for careful implementation
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. Former FDA Commissioner Robert Califf noted that the agency has been experimenting with AI for several years and sees broader opportunities beyond final reviews2
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.As the FDA moves forward with its AI integration plans, balancing innovation with potential risks will be crucial. The outcome of this initiative could set a precedent for AI use in critical government functions and healthcare decision-making processes.
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