FDA Issues Guidance for Industry, Patient-Reported Outcome Measures

In December 2009, the Food and Drug Administration issued a new guidance entitled, Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (the Guidance). In appropriate circumstances, medical product manufacturers can rely on patientreported outcome (PRO) data to support labeling claims. A PRO is a report that comes directly from a patient about his or her health condition without amendment or interpretation of the response by a clinician or anyone else.

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