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UK MHRA Publishes AI Regulatory Strategy
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 ...
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Center for Clinical Trial Innovation furthers FDA’s diversity goals, rare disease drug development
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...
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2024 Life Sciences & Health Care Horizons
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 ...
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FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework
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...
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Commission investigation into termination of pipeline drug: what next for R&D decision-making?
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...
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Clinical Trials Regulation: Transition your clinical trial now
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...
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FDA advises on RWE non-interventional study use as evidence of effectiveness or safety
21 March 2024
Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological...
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New Commission Action Plan to boost biotechnology and biomanufacturing in the EU
20 March 2024
Today, 20 March 2024, the European Commission issued an important Communication aimed at boosting biotechnology and biomanufacturing in the EU. These sectors are identified as key strategic ...
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How to navigate gene editing regulatory hurdles: FDA webinar clarifies newly finalized guidance
14 March 2024
Gene editing (GE) therapies hold immense promise for treating a myriad of diseases. Like most novel products, their development and regulatory approval necessitate careful consideration of...
