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More informationThe European Medicines Agency has released new guidance to support clinical trials during public health emergencies.
The US Food and Drug Administration has introduced a new tool to improve access to adverse event data.
The US Food and Drug Administration has published its latest CDER Guidance Agenda setting out potential guidance documents for drug regulation.
New analysis highlights the economic and healthcare benefits of expanding access to medicines through reclassification.
Singapore has become the first country to achieve the World Health Organization’s highest classification for medical device regulatory systems.
A new paper highlights the worldwide research impact of a major UK health data resource.
The International Medical Device Regulators Forum has opened a public consultation on new guidance for clinical evidence and performance evaluation of IVD medical devices.
New UK guidance explains manufacturing and regulatory expectations for investigational medicines used in clinical trials.
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The FDA has published draft guidance based on the ICH E2D(R1) guideline, which updates international standards for managing and reporting post-approval safety data for medicines.