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New Frontier: FDA Announces Draft Plausible Mechanism Framework for Individualized Ultra-Rare Disease Therapies
Key Takeaways – FDA has proposed a Plausible Mechanism Framework for ultra-rare disease therapies. The February 2026 draft guidance explains how sponsors may demonstrate safety and effectiveness when traditional randomized controlled trials are impracticable due to extremely small patient populations….By: Arnall Golden Gregory LLP
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Is AI-Generated Content a Protectible Asset?
Recent widespread adoption of generative artificial intelligence (GAI) tools has introduced a fundamental legal question: what cognizable right, if any, attaches to content produced by an AI system? As AI-generated text, images, music, source code, and other outputs become embedded in commercial workflows, the absence of a settled framework for ownership presents material risk for…
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SEC and CFTC Sign Updated MOU That Lays Groundwork for Joint Regulation of Crypto
On March 11, 2026, the Securities and Exchange Commission (“SEC”) and Commodity Futures Trading Commission (“CFTC”) announced that they have entered into a new Memorandum of Understanding (“MOU”) to coordinate rulemaking, supervision, examinations and enforcement across areas where the agencies’ jurisdiction overlaps….By: Cadwalader, Wickersham & Taft LLP
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Legal tech clarity starts here: Themes from Chief AI Officer panels in Australia
The conversation around AI in legal has moved decisively on. A clear theme emerged from our recent Chief AI Officer panel discussions: the question is no longer whether to use AI, but how to deploy it responsibly, at scale, and with real return on investment. And the real impact comes from how it is embedded…
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Key Takeaways From the 2026 ICPHSO Annual Meeting – ‘Safety: Community-Collaboration-Commitment’
The International Consumer Product Health and Safety Organization (ICPHSO) recently held its 33rd Annual Meeting in Orlando, Florida. Nearly 800 delegates – regulators, manufacturers, retailers, online marketplaces, testing labs and consumer advocates – gathered under the theme, “Safety: Community-Collaboration-Commitment.”…By: Cooley LLP
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Israel-Iran Conflict: Iran War Live Updates: U.S. Military Attacks Iran’s Oil Export Hub, Trump Says
The strikes on Kharg Island hit military sites, including those storing missiles and mines, a U.S. military official said, adding that economic infrastructure was not targeted. Oil prices have risen by more than 40 percent since the start of the war.
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How the War in Iran Could Help China and Change Asia
American officials have said for years that they would prioritize the Indo-Pacific. Now they’re moving warships, missiles and air defenses out for a war in the Middle East.
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Cuba Acknowledges Talks with Trump Officials For the First Time
President Miguel Díaz-Canel, whose country is rapidly running out of fuel, said the talks were based on “respect for the political systems of both countries.”
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To Fight Iran’s Drones, U.S. Taps Ukraine’s Hard-Earned Knowledge
As Iran has shown, warfare involves far more deadly projectiles than it once did. It’s a problem Ukraine has been dealing with for years.
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A Visit to a Temple at the Heart of the Thailand-Cambodia Conflict
A rare visit to a Khmer temple on Thailand and Cambodia’s border showed how deadly clashes between the two countries have scarred a heritage site.
