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