EU Project Findings To ‘Instil Confidence’ In Using Patient Preference Studies
The European Medicines Agency’s endorsement of a framework that explains how drug and medical device sponsors can use patient preference studies to answer their research questions could help increase confidence in the conduct and acceptability of such studies.
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The EMA is inviting feedback on its plans to ratify, with some caveats, a new framework on how to use patient preferences as input in medical product decision-making. The framework was developed under the EU’s public-private Innovative Medicines Initiative.
The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.
A surge in scientific advice requests in the latter half of 2021 forced the European Medicines Agency to delay the start of some procedures, but the situation has improved considerably since then.