“FDA May highlights; FDA Moves Forward with AI Integration and Stronger Compliance Monitoring
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5/28/20253 min read
FDA May 2025 Regulatory Highlights: Advancing AI Reviews, Global Inspections, and Data Integrity Oversight
May 2025 marked a transformative month for the U.S. Food and Drug Administration (FDA), which advanced three major initiatives that reflect the agency’s commitment to regulatory modernization, transparency, and global quality assurance.
These actions include the expansion of unannounced foreign inspections, the completion of the first AI-assisted scientific review pilot, and new data integrity measures against third-party testing labs. Together, they reinforce the FDA’s goal of protecting public health while ensuring that innovation and compliance progress hand in hand.
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Strengthening Oversight with Unannounced Foreign Inspections
On May 6, the FDA announced that it will significantly expand the use of unannounced inspections at foreign manufacturing facilities supplying medicines and medical products to the U.S.
This decision ends a long-standing double standard in which overseas facilities often received advance notice, while U.S. manufacturers did not. The change follows successful pilot programs in India and China, aimed at ensuring equal regulatory expectations worldwide.
FDA Commissioner Dr. Martin A. Makary emphasized that the move will increase accountability and prevent companies from concealing non-compliance. The agency also clarified that its investigators will no longer accept travel or accommodation support from inspected firms, strengthening independence and objectivity in the inspection process.
For regulatory affairs professionals, this policy underscores the importance of Good Manufacturing Practice (GMP) readiness and continuous documentation accuracy. With unannounced inspections now becoming standard practice, firms must maintain full compliance at all times.
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Accelerating Reviews Through Artificial Intelligence
Two days later, on May 8, the FDA announced the completion of its first AI-assisted scientific review pilot, a historic milestone in the agency’s digital transformation.
The success of the pilot has prompted an agency-wide rollout of generative AI tools across all FDA centers by June 30, 2025.
These tools will automate time-consuming administrative tasks such as data summarization, document comparison, and reference verification—allowing reviewers to focus more on scientific and regulatory evaluation.
Dr. Makary described this as a “game-changing technology” that can complete tasks in minutes that once took several days.
The initiative, led by Chief AI Officer Jeremy Walsh and Sridhar Mantha, former head of CDER’s Office of Business Informatics, represents a broader commitment to improving efficiency, accuracy, and data integrity within the agency’s review process.
For regulatory professionals, this shift highlights a growing need to prepare AI-compatible submissions and understand how automation will shape future regulatory timelines.
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Reinforcing Data Integrity in Global Testing
On May 22, the FDA’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two Chinese third-party testing companies—Mid-Link Technology Testing Co. and Sanitation & Environment Technology Institute of Soochow University (SDWH)—after discovering falsified and unreliable data in biocompatibility and safety studies.
The FDA announced it would reject all data generated by these facilities until the issues are fully corrected. This action follows earlier warning letters in 2024 and forms part of the agency’s broader effort to safeguard the reliability of data used in regulatory submissions.
Commissioner Makary reaffirmed that the FDA has “no room for bad actors” and that inaccurate data can compromise public health, delay product approvals, and disrupt global supply chains.
For regulatory affairs professionals, this underscores the growing importance of verifying third-party data integrity, conducting supplier audits, and maintaining clear documentation trails.
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A Clearer, Smarter Regulatory Future
The FDA’s May 2025 initiatives share a common goal: building a more transparent, efficient, and trustworthy regulatory system.
By pairing technology-driven innovation with stronger global enforcement, the agency is setting new expectations for how products are reviewed, verified, and approved.
For the pharmaceutical and life sciences industry, these actions reflect a new regulatory era—one that demands both scientific adaptability and continuous compliance excellence.
As the FDA continues to modernize, professionals in regulatory affairs will play a key role in bridging innovation, ethics, and public safety in the years ahead.
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