White Paper
Our Perspectives on the US FDA Patient-Focused Drug Development (PFDD) Guidance 3 and 4
Integrating patient experience data into endpoints to inform a COA endpoint strategy
Dec 02, 2020
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The FDA is currently developing a series of four Patient-Focused Drug Development (PFDD) Guidance Documents for the healthcare industry. This insight brief outlines PFDD Guidance 3 and 4, which focuses on COAs adequacy to measure those essential concepts in a clinical trial, and to endpoint development and how COA information can be used to inform regulatory decision-making.

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