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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
06 May 2024
The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate...
News
01 May 2024
On 30 April 2024, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published its strategic approach to AI and the steps it is taking to implement the UK Government's AI ...
Insights and Analysis
01 May 2024
Our 10th annual M&A Year in Review features a 2024 M&A Outlook, which provides insights across the key topics that we expect will influence dealmaking in the months to come:...
News
30 April 2024
The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for...
News
19 April 2024
The U.S. Food and Drug Administration (FDA) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is...
News
18 April 2024
While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...
News
02 April 2024
The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and...
News
02 April 2024
The European Commission has opened a formal investigation into whether Zoetis, a US animal health company, has acted in breach of the abuse of dominance rules by terminating development of...
News
28 March 2024
On 31 January 2025 the Clinical Trials Regulation will become fully applicable to all ongoing clinical trials with medicinal products in the EU. All clinical trials that have been...
