ARTICLE;
BILLING AND CLAIMS;
COMPARATIVE STUDY;
DRUG LABELING;
DRUG PACKAGING;
EUROPEAN MEDICINES AGENCY;
FOOD AND DRUG ADMINISTRATION;
HEALTH CARE ORGANIZATION;
HUMAN;
OUTCOMES RESEARCH;
PATIENT INFORMATION;
PRIORITY JOURNAL;
SYMPTOM;
EMA;
FDA;
LABELING;
PATIENT-REPORTED OUTCOME;
DRUG APPROVAL;
DRUG LABELING;
EUROPE;
HUMANS;
PHARMACEUTICAL PREPARATIONS;
QUALITY OF LIFE;
TREATMENT OUTCOME;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
US Department of Health and Human Services Accessed January 14, 2011
US Department of Health and Human Services. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. 2009. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. [Accessed January 14, 2011].
US Department of Health and Human Services, Food and Drug Administration Accessed January 20, 2012
US Department of Health and Human Services, Food and Drug Administration. Guidance for industry: qualification process for drug development tools. 2010. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf. [Accessed January 20, 2012].
European Medicines Agency, Committee for Medicinal Products for Human Use Accessed August 30, 2013
European Medicines Agency, Committee for Medicinal Products for Human Use. Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. 2005. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific- guideline/2009/09/WC500003637.pdf. Accessed August 30, 2013.
European Medicines Agency, Committee for Medicinal Products for Human Use Accessed October 19, 2012
European Medicines Agency, Committee for Medicinal Products for Human Use. Biomarkers. Available at: http://www.ema.europa.eu/ema/index.jsp?curl= pages/special-topics/general/general-content-000349.jsp&mid= WC0b01ac05800baedb. [Accessed October 19, 2012].
A review of patient-reported outcome labels in the United States: 2006 to 2010
Accessed February 2, 2012
Gnanasakthy A, Mordin M, Clark M, et al. A review of patient-reported outcome labels in the United States: 2006 to 2010. Value Health 2012;15:437-42. Available at: http://www.sciencedirect.com/science/article/pii/ S1098301511036011. [Accessed February 2, 2012].
The role of health-related quality of life data in the drug approval processes in the US and Europe: A review of guidance documents and authorizations of medicinal products from 2006 to 2010
P. Marquis, M. Caron, and M.P. Emery The role of health-related quality of life data in the drug approval processes in the US and Europe: a review of guidance documents and authorizations of medicinal products from 2006 to 2010 Pharm Pharm Med 25 2011 147 160
Evidence of patient reported outcomes in labeling for oncology products: Evaluation of United States and European labels
J. Coombs, C. McBurney, K. Gondek, and K. Copley-Merriman Evidence of patient reported outcomes in labeling for oncology products: evaluation of United States and European labels MAPI Qual Life Newslett 29 2002 1 3
EMA perspective on PRO instrument qualification and harmonization
March 23, 2010, Bethesda, MD
Isaac M, Vamvakas S, Pavlovic M. EMA perspective on PRO instrument qualification and harmonization. Presented at: First Annual Patient Reported Outcomes Consortium Workshop, March 23, 2010, Bethesda, MD.
Reasons for rejection of PRO label claims: An analysis based on a review of PROs among new molecular entities and biologic license applications 2006-2010
May 22, 2011, Baltimore, MD
DeMuro C, Mordin M, Clark M, et al. Reasons for rejection of PRO label claims: an analysis based on a review of PROs among new molecular entities and biologic license applications 2006-2010. Poster presented at: International Society for Pharmacoeconomics and Outcomes Research 16th Annual International Meeting, May 22, 2011, Baltimore, MD.
