EU Project Findings To ‘Instil Confidence’ In Using Patient Preference Studies
Executive Summary
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.
You may also be interested in...
Guidance On Harmonization Of Patient-Focused Drug Development Is Years Away
The International Council for Harmonization has proposed topics for a global PFDD guideline and is expected to begin work on it in the next few years. When finalized, the US FDA will issue it as draft guidance.
EMA Consults On Proposed Framework For Patient Preference Studies
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.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.