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King & Spalding

FDA Aligns U.S. Medical Device Quality System Regulation with International Standards

King & Spalding on

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) and harmonizing them with...more

Mitratech Holdings, Inc

Happy birthday, ChatGPT! Celebrating 1 year with the top 10 milestones in AI governance

Mitratech Holdings, Inc on

A year in review for the ChatGPT (chatbot generative pre-trained transformer) — and a look ahead at the global response to AI & which governance “guardrails” are required. On November 30th, 2023, the world will celebrate...more

King & Spalding

The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards

King & Spalding on

On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more

Hogan Lovells

German court exercises universal jurisdiction: Implications for corporate criminal liability under international law

Hogan Lovells on

On 24 February 2021, the Higher Regional Court (Oberlandesgericht) of Koblenz sentenced a former Syrian secret police officer to a prison term of four and a half years for aiding and abetting crimes against humanity (judgment...more

A&O Shearman

European Central Bank Publishes Paper on Stablecoins

A&O Shearman on

The European Central Bank has published a paper providing an overview of the stablecoins market and looking ahead to its future development. The paper contains no binding rules or guidance and is designed for information...more

A&O Shearman

New EU Directive on Protection of Persons Reporting Breaches of Union Law

A&O Shearman on

A new EU Directive, known as the "EU Whistleblowing Directive", that aims to enhance the enforcement of EU law and policies by providing protection for individuals that report breaches has been published in the Official...more

White & Case LLP

Financial Regulatory Observer – June 2019: Crypto-assets market: Regulators keeping a watchful eye

White & Case LLP on

The impact of crypto-assets on the global financial system continues to be a subject of debate for regulatory and supervisory authorities....more

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