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Machine Learning Regulatory Requirements

Hogan Lovells

Hogan Lovells UK AI Summit 2025: Investment, innovation, and the future of AI regulation

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Anchored by two compelling keynote addresses from The Times’ Technology Business Editor Katie Prescott and Emran Mian CB OBE, Director General for Digital, Technology and Telecoms at DSIT, the summit took stock of the...more

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

Porter Hedges LLP

SEC Shifts Focus to “Rooting Out” AI Abuse

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The Securities and Exchange Commission (SEC) has recently focused on “rooting out” the misuse of artificial intelligence (AI) by publicly traded companies and brokerage firms. On February 20, 2025, the SEC established the...more

Morgan Lewis - As Prescribed

FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more

IR Global

Recursive Artificial Intelligence: Can the Law Keep Up?

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While Artificial Intelligence (AI) has emerged as groundbreaking and significantly impacting various sectors and enhancing quality of life, the chasm between technological advancements and the law is growing by the...more

Gardner Law

FDA Goes All In on AI: What It Means for Your Submissions

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The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more

Alston & Bird

5 Things to Think About When Using AI

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What Happened? As the Trump Administration’s deregulatory, pro-innovation approach to emerging technology moves forward, the use of artificial intelligence has taken center stage, and it is clear that the Administration...more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

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The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

King & Spalding

FDA Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review

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On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more

Troutman Pepper Locke

Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast

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Join Troutman Pepper Locke Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this episode of The Good Bot, Brett Mason and Emma Trivax delve...more

Hogan Lovells

FDA advances AI-powered review of medical product applications

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If the initiative proceeds as planned, it will mark a pivotal shift in the regulatory landscape, introducing both efficiencies and novel questions related to the reliability and validity of the AI reviews, as well as...more

McDermott Will & Emery

Investment Opportunities in TechBio and Pharma Services - European Health & Life Sciences Symposium 2025

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In April 2025, McDermott once again hosted its annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

Wilson Sonsini Goodrich & Rosati

All Eyes on AI: Regulatory, Litigation, and Transactional Developments – Q1 2025

The firm is pleased to distribute the Q1 2025 edition of All Eyes on AI: Regulatory, Litigation, and Transactional Developments, which closely follows the evolving regulatory landscape for artificial intelligence (AI) in the...more

Pillsbury - Global Sourcing Practice

Legal Definitions of AI: Considerations and Common Threads

By now, we all know what AI is. Some of us use ChatGPT as our search engine, confidant, secretary, travel agent, and much more. Others, at least, are acutely aware that AI exists, because everyone else is talking about it,...more

BCLP

HK Releases Guideline Concerning Generative AI

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On 15 April 2025, the Hong Kong Government’s Digital Policy Office published the Hong Kong Generative Artificial Intelligence Technical and Application Guideline (“Guideline”), which aims to provide operational guidance for...more

Holtzman Vogel Baran Torchinsky & Josefiak

Early Returns Podcast - Oliver Roberts: AI and the Law, and an Education

Jan Baran speaks with Artificial Intelligence (AI) legal expert. lawyer and teacher, Oliver Roberts, to speak about AI, its birth, its forms, and how people have historically used and are currently using the ever-changing...more

Farella Braun + Martel LLP

Copyright Office Weighs in on Use of Copryighted Works for LLM Training

A day before the firing of the head of the U.S. Copyright Office, the third installment of the office's series of reports on copyright issues and AI was released. The 113-page document covers a lot of ground, not the least of...more

DLA Piper

Becoming the World’s Leading AI Continent: The Commission’s “AI Continent Action Plan”

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The European Commission has shortly published its “AI Continent Action Plan” and, doing so, set itself no less a task than winning the global race for AI leadership and making Europe the leading AI continent. This shall be...more

BakerHostetler

AI Audit Best Practices for Building User and Global Trust

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Artificial intelligence (AI) as a field encapsulates machine learning, deep learning and generative AI. As the impact of these technologies continues to grow, industry leaders and regulators have been grappling with how to...more

DLA Piper

For Your AIs Only: Agentic AI Steps Out of the Shadows

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Agentic AI can independently act and adapt to changing environments without relying on existing data patterns like GenAI. Agentic AI promises more goal-oriented autonomous systems, ideal for matters involving complex...more

McDermott Will & Emery

Quit Monkeying Around: FDA Offers Faster Approval Times in Bid to Phase Out Animal Testing

On April 10, 2025, the US Food and Drug Administration (FDA) announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug...more

Hogan Lovells

FDA animal testing phaseout urges AI-based trial alternatives, organoids, other “NAMs”

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The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal antibody therapies and other drugs and biological products “with more effective,...more

Jones Day

OMB Directs Agencies to Accelerate AI Adoption and Devise Governance Strategy

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The Office of Management and Budget releases highly anticipated guidance to federal agencies on the use and deployment of artificial intelligence and how to manage its risks....more

MoFo Life Sciences

Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Ropes & Gray LLP

Adversarial Machine Learning in Focus: Novel Risks, Straightforward Legal Approaches

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The Artificial Intelligence and Machine Learning (“AI/ML”) risk environment is in flux. One reason is that regulators are shifting from AI safety to AI innovation approaches, as a recent DataPhiles post examined. Another is...more

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