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Regulatory Requirements Life Sciences

McDermott Will & Emery

McDermott HealthEx 2025: McKinsey Key Takeaways

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McDermott HealthEx convened more than 1,300 of the most influential leaders in healthcare and life sciences. The event emphasized creativity, transformation, and growth, with sessions dedicated to innovation, AI-powered...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

Hogan Lovells

AI Summit panelists weigh emerging data & privacy risks for novel technology

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Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including data and privacy...more

Hogan Lovells

AI Summit panelists mull complexities of EU’s AI Act, global compliance considerations

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Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including evolving regulatory...more

Jones Day

Revolutionizing EU Design Protection: Key Changes Under the New Designs and Models Regulation

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May 1, 2025, marked the entry into force of most provisions of Phase I of the new Regulation (EU) 2024/2822, which forms part of the "Designs and Models Package" adopted within the European Union. This text, in addition to...more

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

Lathrop GPM

Trump Executive Order Restricts Funding for “Dangerous Gain-of-Function Research”

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On May 5, the Trump administration issued Executive Order 14292, “Improving the Safety and Security of Biological Research,” which effectively ends federal funding for “dangerous gain-of-function research” and other life...more

Arnall Golden Gregory LLP

Surprise, Surprise: FDA Announces Plans to Increase Number of Unannounced Inspections at Foreign Manufacturing Facilities

In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more

Baker Donelson

DOJ Bulk Data Rule: Key Takeaways for Healthcare and Life Sciences

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The Data Security Program (DSP), implemented by the Department of Justice's National Security Division (DOJ/NSD) under Executive Order 14117 (Preventing Access to Americans' Bulk Sensitive Personal Data and United States...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

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Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

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Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Latham & Watkins LLP

FDA and NIH Announce Initiatives to Reduce Animal Testing and Encourage Alternative Methodologies

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The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more

McGuireWoods LLP

Insights From the 21st Annual McGuireWoods Healthcare Private Equity and Finance Conference: Part 1

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McGuireWoods held its 21st Annual Healthcare Private Equity and Finance Conference in Chicago, May 13-15, 2025. This premier conference brought together leading healthcare investors, lenders, executives, consultants and...more

Hogan Lovells

EMA’S NEW WORK PLAN: Leveraging data and AI to encourage innovation and research

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The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI). On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with...more

Sheppard Mullin Richter & Hampton LLP

Reflections on the FDLI 2025 Annual Conference – Differing Tones, Shared Goals

From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of...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

A&O Shearman

The future of the robotics metaverse in the healthcare sector

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On 26 February 2025, the European Economic and Social Committee (EESC) adopted an opinion addressing the integration of robotics and the metaverse in healthcare. This forward-looking document outlines the opportunities and...more

MoFo Life Sciences

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

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AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must...more

Epstein Becker & Green

Will Colorado’s Historic AI Law Go Live in 2026? Its Fate Hangs in the Balance in 2025

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On May 17, 2024, Colorado Governor Jared Polis signed Colorado’s historic artificial intelligence (AI) consumer protection bill, SB 24-205, colloquially known as “Colorado’s AI Act” (“CAIA”), into law....more

Hogan Lovells

How Trump’s reshoring EO affects plans to build or expand a domestic drug manufacturing facility

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Investments in new (“greenfield”) or expanded (“brownfield,” “retrofit”) domestic manufacturing capabilities require years of strategic planning and capital expenditure. Even with the announcement of near-term incentives and...more

Morgan Lewis

Exploring the Legal Frontier of Space and Satellite Innovation

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For companies in the aerospace and defense industry, the future of space innovation involves far more than rockets and satellites. Intellectual property, technology transfers, data privacy, and life sciences are among the...more

Robins Kaplan LLP

Generic Launches

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Abbreviated New Drug Applications and 505(b)(2) Applications - This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug...more

Akin Gump Strauss Hauer & Feld LLP

Improving the Safety and Security of Biological Research (Trump EO Tracker)

This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...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

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

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