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Patient-Focused Drug Development: US FDA’s Guidance Development Effort Passes The Mid-Point

 
• By Sue Sutter

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.

Pink Sheet Perspectives 2019 to 2020
Patient-focused drug development is expected to be a topic in PDUFA VII talks that begin in 2020.

More than halfway through the US Food and Drug Administration’s guidance development effort on patient-focused drug development, the agency is receiving plaudits for its work, but industry and patient advocates continue to voice some key concerns that could become topics for discussion in the next round of user fee negotiations.

In 2019, the agency released the second of four draft guidance documents required under the 21st Century Cures Act and...

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