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As organizations deploy artificial intelligence (AI) across current good manufacturing practices (cGMP) platforms, uncertainty and a lack of AI-specific regulations are slowing adoption.

The European Commission has published a report on the cost-effectiveness of standards-driven eHealth interoperability; the exchange of data between IT systems.

DDCs are human medicines that include a medical device.

Last week, MedTech Europe, the European trade association representing the medical technology industries, published a position paper calling on the European Commission ...

On June 14, 2023, an overwhelming majority of the European Parliament (Parliament) recently voted to pass the Artificial Intelligence Act (AI Act), marking another major step toward the legislation becoming law.

An overview of President Biden's biggest policy priorities, including what was covered in the State of the Union (SOTU), and potential next steps.

On February 5, 2021, the UK's Supreme Court confirmed the extraterritorial limits of the Serious Fraud Office's (SFO) investigatory powers under the Criminal Justice Act 1987 (the Act).

As the UK comes to grips with the government's "roadmap" out of the coronavirus pandemic, attention turns to how specific sectors will fare in the coming months.

In February 2018, the Integrated Research Application System (IRAS) issued revised versions of the template model Clinical Trial Agreement (mCTA) and Clinical Research Organisation ...

The UK government published its Medicines and Medical Devices Bill (the Bill) on 13 February 2020.

The UK Department of Health and Social Care (DHSC) has proposed to set the repayment percentage on sales of branded "newer" prescription-only medicines to the NHS at 16.5% for 2026...

On 31 July 2025, the UK government published a statement of policy intent, setting out its initial thinking on an Early Access Service (EAS) for innovative medical devices.

In today's judgment, the UK Supreme Court held that rights-holders should bear the costs of implementing website blocking injunctions to prevent IP infringement.

Kaye Scholer Aviation Finance & Leasing Practice Co-Head and London Office Managing Partner Philip Perrotta is once again prominently featured in the most recent edition of The International Comparative Legal Guide to: Aviation Law.

The Antitrust Division of the US Department of Justice (the Division) historically has disfavored using deferred prosecution agreements (DPAs) to resolve criminal antitrust violations.

Last week, a Connecticut district court unsealed a criminal complaint and affidavit alleging that a former aerospace executive, along with managers and executives of several suppliers of engineering services...

Senior congressional antitrust leaders on both sides of the Capitol are taking steps to transition a long-running investigation into competition practices in the technology sector into legislative action.

On August 21, the U.S. Department of Justice (DOJ), Antitrust Division announced deferred prosecution agreements (DPAs) resolving criminal antitrust charges against Teva Pharmaceuticals USA Inc.