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Regulatory Authority Disclosure Requirements Risk Management

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Pivots on Publishing Complete Response Letters, Raising SEC Disclosure and Securities Litigation Implications

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more

Conyers

Responding to Regulatory Notices: A Litigator’s Perspective

Conyers on

There are a variety of information gathering and other compulsory notices available to regulatory and enforcement agencies based in the Cayman Islands, as tools these agencies can draw on to carry out their functions. In this...more

Holland & Knight LLP

Colorado Legislature Approves AI Bill Targeting "High-Risk" Systems and AI Labeling

Holland & Knight LLP on

The Colorado legislature passed the Colorado Artificial Intelligence Act (SB 205 or the Act) on May 8, 2024. If approved by Gov. Jared Polis, it will be the first law in the U.S. to impose specific requirements intended to...more

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