Key Takeaways – FDA explains what must be “new” to qualify for three years of non-patent market exclusivity. In a…
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Key Takeaways – FDA has proposed a Plausible Mechanism Framework for ultra-rare disease therapies. The February 2026 draft guidance explains…
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Recent widespread adoption of generative artificial intelligence (GAI) tools has introduced a fundamental legal question: what cognizable right, if any,…
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On March 11, 2026, the Securities and Exchange Commission (“SEC”) and Commodity Futures Trading Commission (“CFTC”) announced that they have…
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The conversation around AI in legal has moved decisively on. A clear theme emerged from our recent Chief AI Officer…
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The International Consumer Product Health and Safety Organization (ICPHSO) recently held its 33rd Annual Meeting in Orlando, Florida. Nearly 800…
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In remarks delivered at the American Bankers Association’s Washington Summit on March 11, 2026, FDIC Chairman Travis Hill outlined the…
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A recent federal court ruling has delivered a significant wake-up call to anyone who has used an artificial intelligence (AI)…
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AI-enabled smart glasses – which combine eyewear with real-time audio, video, and AI functionality – are now entering the workplace.…
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