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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Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.
With draft guidance allowing for drugs that improve heart failure symptoms but do not improve – or may even decrease – survival, the legal community could help establish development metrics.
US FDA plans new guidances on real-world data, clinical trial statistics, and patient input in coming this year.