Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for Industry
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Clinical - Medical, Good Clinical Practice (GCP)
Published
December 9, 2009
Last updated
May 15, 2020
Description
A guidance document on using patient-reported outcome measures in medical product development to support labeling claims.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)