At the end of June, Texas enacted the “Texas Responsible Artificial Intelligence Governance Act” (the “Act”), adding to the patchwork of growing AI laws. This summary addresses the Act’s most significant provisions.
Introduction
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This initiative formalizes the agency’s long-building effort to incorporate New Approach Methodologies (NAMs) into regulatory review and follows the release of draft guidance
The Fedtrade® podcast recently interviewed Eugene Laney, President and CEO of the American Association of Exporters and Importers (AAEI). The AAEI represents an international community of trade compliance professionals responsible for complying with and influencing the laws — both domestic and global — that govern the export and import of goods.
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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
A new lawsuit filed yesterday in the U.S. District Court for the District of Maryland has the potential to reshape the contours of health information exchange in the United States. Audacious Inquiry, LLC, a Baltimore-based health IT innovator now owned by PointClickCare, together with its subsidiary Collective Medical Technologies, has sued the Chesapeake Regional Information
TIn one of its largest coordinated enforcement efforts to date, the Department of Justice recently announced charges against more than 300 defendants in connection with alleged healthcare fraud schemes.
On June 10th, Sheppard Mullin partner Carolyn Metnick and associate Esperance Becton, in collaboration with Marsh McLennan, presented the CLE webinar, “Navigating Healthcare Risks in a Rapidly Evolving Patient and Provider Centered AI Landscape.” The session addressed the growing legal, operational, and ethical risks of AI adoption in healthcare, emphasizing the importance of thoughtful governance
On 7 July 2025, the European Commission launched a public consultation that could mark the start of a turning point for how Artificial Intelligence (AI) is used in pharmaceutical manufacturing. The consultation proposes significant updates to the EU Good Manufacturing Practice (GMP) guidelines—specifically Chapter 4 on Documentation, Annex 11 on Computerised Systems, and, for the
The recently enacted 2025 Reconciliation law in its initial iteration had within it a 10 year moratorium on state regulation of artificial intelligence (AI). The provision was stripped out of the final law by an amendment proposed by Senator Marsha Blackburn (R. TN) who, at the time of the debate, decried the inability of the
The revised MDCG 2019-11 guidance on qualification and classification of software (the Revised Guidance) introduces a series of clarifications and expansions that impact how software is qualified and classified as a medical device under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). While the core principles remain unchanged, the Revised Guidance