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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
News
08 February 2023
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
31 January 2023
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...
News
19 January 2023
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...
News
11 January 2023
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...
News
18 November 2022
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...
News
15 November 2022
The U.S. Food and Drug Administration (FDA) recently issued the draft guidance “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health ...
News
08 November 2022
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...
News
26 October 2022
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...
News
11 October 2022
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,”...
