FDA and AI in the Drug Review Process

     

 

For Immediate Release:

May 08, 2025

If you have been reading my blogs, you probably know that my last job before

retirement was with the FDA Center of New Drugs, involved with the Chemistry,

 Manufacturing and Control reviews of new Anti-Infective Drug Products. My

role during my first 6 years was a Chemistry reviewer. Later on I was promoted 

to Chemistry Team Leader after getting my GS-14 expertise. Thus the subject 

of Drug Reviews inspired me to repost this FDA Press Release dated 

May 08-25.  If you are an AI enthusiast and interested on review of New drugs

this is  MUST Read for You. Here's the FDA release for your reading Pleasure.

  

"In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., 

M.P.H., today announced an aggressive timeline to scale use of artificial

 intelligence (AI) internally across all FDA centers by June 30, 2025, following 

the completion of a new generative AI pilot for scientific reviewers.

“I was blown away by the success of our first AI-assisted scientific

 review pilot. We need to value our scientists’ time and reduce the 

amount of non-productive busywork that has historically consumed

 much of the review process. The agency-wide deployment of these 

capabilities holds tremendous promise in accelerating the review

 time for new therapies,” said Dr. Makary.

The generative AI tools allow FDA scientists and subject-matter experts to

 spend less time on tedious, repetitive tasks that often slow down the review

 process.

“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 (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, 

Office of New Drugs in FDA’s Center for Drug Evaluation and Research 

(CDER).

To reflect the urgency of this effort, Dr. Makary has directed all FDA centers

 to begin deployment immediately, with the goal of full integration by the end

 of June. Work will continue to expand use cases, improve functionality and 

adapt to the evolving needs of each center after June 30. By that date,

 all centers will be operating on a common, secure generative AI system

 integrated with FDA’s internal data platforms.

“There have been years of talk about AI capabilities in frameworks, 

conferences and panels but we cannot afford to keep talking. It is time 

to take action. The opportunity to reduce tasks that once took days to

 just minutes is too important to delay,” said Dr. Makary.

Looking ahead, the FDA plans to expand generative AI capabilities—across 

all centers using a secure, unified platform. Future enhancements will focus 

on improving usability, expanding document integration, and tailoring outputs 

to center-specific needs, while maintaining strict information security and 

compliance with FDA policy.

The agency-wide rollout is being coordinated by Jeremy Walsh, the FDA’s

 newly appointed Chief AI Officer and Sridhar Mantha. Walsh previously led 

enterprise-scale technology deployments across federal health and

 intelligence agencies and Mantha recently led the Office of Business

 Informatics in CDER.

The agency will continue to assess performance, gather user feedback and

refine features to support the evolving needs of FDA staff and advance its

 public health mission. Additional details and updates on the initiative will be 

shared publicly in June.

Meanwhile, here are 50 English Proverbs, You should Use in Your

Speech

 

are hatch.

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