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Holland & Knight LLP

FDA Announces Plan to Phase Out Animal Testing Requirement

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The U.S. Food and Drug Administration (FDA) on April 10, 2025, announced a significant policy shift aimed at reducing its reliance on animal testing for drug development and incorporating new approach methodologies (NAMs)...more

Faegre Drinker Biddle & Reath LLP

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Faegre Drinker Biddle & Reath LLP on

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more

Faegre Drinker Biddle & Reath LLP

Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape

Faegre Drinker Biddle & Reath LLP on

Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...more

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