1. U.S. Food and Drug Administration(2009)Guidance for Industry – Patient‐Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf.
2. Regulatory Issues for Health-Related Quality of Life— PhRMA Health Outcomes Committee Workshop, 1999
3. Incorporating the Patient's Perspective into Drug Development and Communication: An Ad Hoc Task Force Report of the Patient-Reported Outcomes (PRO) Harmonization Group Meeting at the Food and Drug Administration, February 16, 2001
4. U.S. Food and Drug Administration(2013)PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 Through 2017 http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
5. U.S. Food and Drug Administration(2015)PDUFA V Clinical Outcome Assessment Development and Implementation: Opportunities and Challenges Public Workshop meeting transcript http://www.fda.gov/downloads/Drugs/NewsEvents/UCM448136.pdf.