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Patient Experience Data: Industry Seeks US FDA Clarity On Submission Pathway And Labeling

 
• By Sue Sutter

Dedicated mechanism may be needed for biopharma sponsors and patient advocacy groups to talk to agency about patient experience data collection and analysis; industry wants FDA to clarify where such data will appear in product labeling, while advocates ask agency to be mindful of limited resources many patient groups have for conducting such research.

Data Collection - Three Arrows Hit in Red Target

The US FDA should consider establishing dedicated mechanisms for discussing and submitting patient experience data, industry representatives and patient groups said in comments on the agency's patient-focused drug development (PFDD) initiative.

FDA also should clarify how it intends to use such data in regulatory decision-making and where such data may fit...

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