US FDA guidance: Apropos of PROs

PharmacoEconomics

Volumn 24, Issue 9, 2006, Pages 833-836

  Kind, Paul ^a  

^a UNIVERSITY OF YORK   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG LABELING; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HEALTH STATUS; MEDICAL LITERATURE; MEDICAL PRACTICE; MEDICAL RESEARCH; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE; SELF REPORT; UNITED STATES;

DRUG LABELING; HEALTH STATUS; HUMANS; PATIENT SATISFACTION; QUALITY-ADJUSTED LIFE YEARS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33748352578     PISSN: 11707690     EISSN: 11707690     Source Type: Journal    
DOI: 10.2165/00019053-200624090-00001     Document Type: Editorial

References (3)

1. Acquadro C, Berzon R, Dubois D, et al. Incorporating the patient's perspective into drug development and communication: PRO Harmonization Group. Value Health 2003; 6 (5): 522-31
2. Giuliani RW. The next phase of quality of life: creating a more civil city. New York, 1998 Feb 22 [online]. Available from URL: http://www.nyc.gov/ html/rwg/html/98a/quality.html [Accessed 2006 Aug 17]
3. US Department of Health and Human Services Food and Drug Administration. Draft guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims [online]. Available from URL: http://www.fda.gov/CDER/guidance/5460dft.pdf [Accessed 2006 Aug 17]