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PDUFA VI: Price Tag For Patient Experience Data Validation May Go Up

 
• By Derrick Gingery

FDA wants to advance PRO projects through the user fee reauthorization, but ironically is having difficulty quantifying how much support it might need.

FDA efforts to systematize patient experience data appear likely to be at least a discussion topic for PDUFA VI negotiations and potentially an area for continued fee support.

Agency officials want to figure pragmatic and appropriate methods to incorporate patient experience data for use in clinical trials.

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More from North America

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