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FDA Names First Chief AI Officer: A Bold Step Toward Faster, Smarter Drug Reviews

The future of healthcare regulation just got a lot more intelligent.

In a move that signals deep commitment to digital transformation, the U.S. Food and Drug Administration (FDA) has appointed Jeremy Walsh as its first-ever Chief Artificial Intelligence Officer. This pivotal role will lead the charge in integrating AI across the agency, modernizing how therapies are reviewed, regulated, and ultimately delivered to patients.

Leading with Intelligence: Jeremy Walsh at the Helm

Walsh, formerly Chief Technologist at Booz Allen Hamilton, brings decades of experience in AI, cloud innovation, and large-scale digital transformation. Now, he’s tasked with reimagining the FDA’s operational backbone—ushering in a new era where generative AI and intelligent systems can do what once took days, in mere minutes.

The implications for life sciences, pharma, and biotech are enormous. This isn’t just about speed. It’s about trust, transparency, and scaling regulatory insights with precision.

GenAI at Work: cderGPT and Beyond

Among the agency’s flagship initiatives is cderGPT, a generative AI tool co-developed with OpenAI and purpose-built for the Center for Drug Evaluation and Research (CDER). The goal? Cut down manual review work, reduce delays, and allow scientists to focus on what matters: evaluating safety and efficacy.

“This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong Liu, deputy director of CDER’s Office of Drug Evaluation Sciences.

By June, generative AI tools are expected to be deployed across all FDA centers. This isn’t a proof of concept - it’s production-ready AI in action.

What This Means for the Industry

The message for biotech leaders, pharma innovators, and health tech disruptors is clear: the regulatory landscape is evolving - and AI is at the center of that shift. With Jeremy Walsh driving strategy and tools like cderGPT already proving their value, the FDA is demonstrating what it means to move from AI exploration to execution.

At Launch, we believe in building intelligent foundations that make transformation real. The FDA’s appointment of a Chief AI Officer is a model for what happens when leadership, innovation, and purpose align.  

Healthcare’s future is being built now, and it’s intelligent by design. Discover how Launch helps organizations become AI-first - from strategy to execution.

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The future of healthcare regulation just got a lot more intelligent.

In a move that signals deep commitment to digital transformation, the U.S. Food and Drug Administration (FDA) has appointed Jeremy Walsh as its first-ever Chief Artificial Intelligence Officer. This pivotal role will lead the charge in integrating AI across the agency, modernizing how therapies are reviewed, regulated, and ultimately delivered to patients.

Leading with Intelligence: Jeremy Walsh at the Helm

Walsh, formerly Chief Technologist at Booz Allen Hamilton, brings decades of experience in AI, cloud innovation, and large-scale digital transformation. Now, he’s tasked with reimagining the FDA’s operational backbone—ushering in a new era where generative AI and intelligent systems can do what once took days, in mere minutes.

The implications for life sciences, pharma, and biotech are enormous. This isn’t just about speed. It’s about trust, transparency, and scaling regulatory insights with precision.

GenAI at Work: cderGPT and Beyond

Among the agency’s flagship initiatives is cderGPT, a generative AI tool co-developed with OpenAI and purpose-built for the Center for Drug Evaluation and Research (CDER). The goal? Cut down manual review work, reduce delays, and allow scientists to focus on what matters: evaluating safety and efficacy.

“This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong Liu, deputy director of CDER’s Office of Drug Evaluation Sciences.

By June, generative AI tools are expected to be deployed across all FDA centers. This isn’t a proof of concept - it’s production-ready AI in action.

What This Means for the Industry

The message for biotech leaders, pharma innovators, and health tech disruptors is clear: the regulatory landscape is evolving - and AI is at the center of that shift. With Jeremy Walsh driving strategy and tools like cderGPT already proving their value, the FDA is demonstrating what it means to move from AI exploration to execution.

At Launch, we believe in building intelligent foundations that make transformation real. The FDA’s appointment of a Chief AI Officer is a model for what happens when leadership, innovation, and purpose align.  

Healthcare’s future is being built now, and it’s intelligent by design. Discover how Launch helps organizations become AI-first - from strategy to execution.

Back to top

More from
Latest news

Discover latest posts from the NSIDE team.

Recent posts
About
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