A new systematic analysis of FDA regulatory correspondence provides a more balanced picture of artificial-intelligence enforcement than individual headlines may suggest. Researchers reviewed all 3,011 FDA Warning Letters issued between 1 January 2022 and 28 September 2026 and found only seven that referred to AI. Just one letter directly treated a company’s use of AI as a current Good Manufacturing Practice violation.
The study, published on 31 October 2026 in Discover Pharmaceutical Sciences, also examined publicly released Form FDA 483 observations and Establishment Inspection Reports containing AI-related references.
The European Union has reached an important milestone in the practical implementation of the Artificial Intelligence Act.
On 14 October 2026, the European Commission published in the Official Journal of the European Union the reference to EN 18286:2026 – Artificial Intelligence – Quality Management System for EU AI Act Regulatory Purposes.
It is the first harmonised standard formally cited in support of the EU AI Act.
The standard translates the quality-management-system requirements of Article 17 of Regulation (EU) 2024/1689 into an operational and auditable framework for providers of high-risk AI systems.
For pharmaceutical and life-sciences organisations, the most important message is not that every AI application now requires a new QMS.
The European Medicines Agency has opened a public consultation on a new draft chapter of the Data Quality Framework for EU medicines regulation.
Published on 19 October 2026, the document addresses the collection, management and submission of adverse drug-reaction reports for both human and veterinary medicines.
The consultation remains open until:
14 December 2026.
Although the document is primarily about pharmacovigilance data quality, it contains an unusually clear regulatory statement about the use of artificial intelligence in safety-data management.