Robert A. Kagan discusses how litigation shapes regulation, policymaking, and accountability in the United States.

Announcing a new article publication for BIO Integration journal. The development of a comprehensive regulatory model for medical devices is essential to ensure the safety, efficacy, and quality of ...

The dream of directly effective supra-national legislation, applying in exactly the same way in each EU Member State: an EU Regulation should (in theory) provide the same protections in the same way ...

Regulators around the world differ in their approach to model risk management (MRM) regulation – including their definitions of what a model is. While some are more prescriptive, others such as the UK ...