EMA's draft reflection paper promotes using patient experience data in drug regulation to enhance decision-making processes. Patient perspectives, such as quality of life, complement scientific data ...
The European Medicines Agency (EMA) has published a reflection paper discussing key considerations for single-arm clinical trials that are used as pivotal evidence in regulatory filings. A public ...
The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it. The European Medicines Agency (EMA) published a draft reflecting paper ...
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