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US FDA Should Explain How It Uses Patient Experience Data In Drug Approvals – Report

 
• By Sue Sutter

Review documents do not always reflect whether PED was considered as part of an application, and stakeholders cannot easily determine how such data are used in the agency’s regulatory decision-making, an independent consultant review found.

Trajectory
Product sponsors and other stakeholders say FDA is on a good trajectory when it comes to using patient experience data. • Source: Alamy

The US Food and Drug Administration should more clearly explain how it uses patient experience data in its approval decisions for drugs and biologics, an independent consultant has recommended.

Applicants, patients, caregivers and other stakeholders cannot easily determine how the FDA uses patient experience data (PED) in regulatory decision-making, the Eastern Research Group found in a recent assessment.

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