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As the Covington team discussed in a recent article, use of AI models in biopharma is on the rise, with use cases spanning the life cycle of drugs and biologics, including product development, manufacturing, and pharmacovigilance. Recently, FDA announced its own intentions to aggressively scale the use of AI in regulatory review and launched

There is an ongoing debate in Brussels about the circumstances under which AI-based safety components integrated into radio equipment are subject to the requirements for high-risk AI systems of the EU Artificial Intelligence Act 2024/1689 (the “AI Act”). The debate is particularly relevant because, if AI-based safety components are considered high-risk under the AI Act,

Federal legislation to “pause” state artificial intelligence regulations will not become law—for now—after the Senate stripped the measure from the budget reconciliation package, the One Big Beautiful Bill Act (H.R. 1).

The Senate voted 99–1 to strike the moratorium language from the bill during a marathon 27-hour “vote-a-rama” on July 1. The Senate voted 51–50,