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New instructions from AEMPS on clinical investigations with medical devices in Spain

In order to comply with the provisions of the EU Medical Device Regulation (EU MDR) and the (coming) Spanish MDR, the Agencia Española de Medicamentos y Productos Sanitarios (Spanish ...

Insights and Analysis

Life Science Law Update – Key developments for pharma and device companies in EU and EU Big Five

In this first issue of our quarterly Life Science Law Update, our teams highlight key trends across life sciences regulatory, corporate, compliance, competition, and privacy throughout the...


FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act...


U.S. Congress embraces FDA’s approach to clinical trial diversity in new Omnibus legislation

In the waning days of 2022, Congress passed the omnibus spending legislation to provide funding for the federal government through September 2023. The legislation contains numerous reforms...


Cell, tissue and gene therapies – Regulatory challenges and responses in Australia

Australian regulation of cell, tissue, and gene therapies (CTGT) is relatively new, with the regulatory framework for biological medical products first being introduced in 2011. A decade...


FDA Breakthrough Devices Program guidance targets health inequality

The U.S. Food and Drug Administration (FDA) recently issued the draft guidance “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health ...


Seeking harmony: FDA to align its human subject research regulations with Common Rule

Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject protection regulations and the Federal...


UK MHRA delays new medical devices legislation until July 2024

The United Kingdom medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has announced that the upcoming changes to UK medical device legislation will...


FDA to regulate more AI & software tools as devices, guidance indicates

In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,”...

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