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From Listening To Advising: The Maturation Of US FDA's Patient-Focused Drug Development Program

 
• By Sue Sutter

With the disease-area meetings required under PDUFA V now behind it, FDA is turning its attention to guiding sponsors and advocacy groups on how to systematically collect patient experience data for use in drug development and regulatory decision-making. At least two guidance documents and a new data repository are on tap for 2018.

Pink Sheet Perspectives 2017 - 2018

The past year marked the end of the first chapter, and the beginning of the second, on the US FDA's formal efforts to promote a more patient-centered approach to the development and regulation of drugs and biologics.

In 2017, the agency transitioned from simply listening to patients' experiences about symptom burden and currently available treatments in patient-focused drug development (PFDD) meetings, to developing formal advice on systematically...

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