FDA Launches Agency-Wide AI Rollout by 2025

Today, the US Food and Drug Administration (FDA) announced an accelerated timeline to implement artificial intelligence (AI) technologies across all its centers by June 30, 2025. This announcement follows the success of a generative AI pilot aimed at streamlining scientific review processes. The decision represents a historic step in the agency’s ongoing modernization efforts.¹

FDA Commissioner Martin A. Makary, MD, MPH, stated that the pilot significantly reduced the time needed for routine scientific review tasks. The program, which tested generative AI tools with subject-matter experts, was reported to have improved workflow efficiency by automating repetitive, time-consuming components of regulatory review. In a news release, Makary said, “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.”

Jinzhong Liu, deputy director of the Office of Drug Evaluation Sciences within the Center for Drug Evaluation and Research (CDER), echoed this sentiment, noting that tasks which previously required multiple days to complete could now be finalized in a matter of minutes using AI support. The tools used in the pilot incorporated generative AI models capable of processing vast amounts of regulatory data, synthesizing documentation, and producing summaries to aid scientific reviewers.

In response to the pilot's success, Makary has directed all FDA centers to begin AI implementation immediately. The goal is for each center to operate on a unified and secure generative AI platform that integrates with FDA’s internal systems by the end of June 2025. After this milestone, the FDA plans to continue refining the system by improving functionality, expanding the range of supported tasks, and adapting the technology to meet the unique demands of each center.

Oversight for the agency-wide deployment will be led by Jeremy Walsh, the FDA’s newly appointed chief AI officer, and Sridhar Mantha, a former director of the Office of Business Informatics in CDER. Together, they will guide the FDA’s strategic AI rollout, with a focus on performance evaluation, user feedback, and long-term sustainability.

Future enhancements to the AI platform will include improved document integration, more intuitive user interfaces, and the ability to tailor outputs to the specific regulatory and scientific contexts of each center. Public updates on the initiative are expected to be shared by June 2025.

This move by the FDA marks a notable shift from theoretical discussions around AI adoption in government to concrete, agency-wide implementation. Whether this initiative will serve as a model for other regulatory bodies remains to be seen, but the agency’s commitment to modernizing its processes suggests a significant step forward in public health administration.

AI's role in transforming health care has already been well demonstrated, including in the field of dermatology. A growing body of research highlights how machine learning models have improved diagnostic accuracy for skin diseases. Recent research underscored how AI tools are being leveraged to identify skin lesions with high sensitivity and specificity.² Moreover, applications in cosmetic dermatology are helping clinicians develop personalized treatment plans using AI-powered image analysis.³ Tools like the SkinChange.AI mobile app also show promise in detecting early signs of skin changes with considerable accuracy, potentially aiding in earlier interventions.⁴ These innovations exemplify AI’s growing impact across specialties, reinforcing the FDA’s push toward broader AI adoption within regulatory science.

References

1. FDA announces completion of first AI-Assisted scientific review pilot and aggressive agency-wide AI rollout timeline. News Release. US FDA. Published May 8, 2025. Accessed May 8, 2025. https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai
2. Nielsen JPS, Grønhøj C, Skov L, et al. Usefulness of the large language model ChatGPT (GPT-4) as a diagnostic tool and information source in dermatology. JEADV Clin Pract. 2024; 1–6. https://doi.org/10.1002/jvc2.459
3. Kania B, Montecinos K, Goldberg DJ. Artificial intelligence in cosmetic dermatology. J Cosmet Dermatol. 2024; 00: 1-7. doi:10.1111/jocd.16538
4. Grove GL, Reedtz G, Vangsgaard B, et al. Artificial intelligence smartphone application for detection of simulated skin changes: An in vivo pilot study. Skin Res Technol. doi: 10.1111/srt.70056