PRO | Drug Development Consultant and Regulatory Consultant

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Drug Regulators, FDA, CDER, Publish Guidance on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

Filed in labeling,licensing, December 29, 2009, 10:24 am claims, instruments, medical lableling, Patient-reported outcome, PRO

This guidance describes how the Food and Drug Administration (FDA) reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO) instruments used to support claims in approved medical product labeling.

Drug Development Consultant and Regulatory Consultant

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Drug Regulators, FDA, CDER, Publish Guidance on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

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