A Review of FDA Warning Letters and Notices of Violation Issued for Patient-Reported Outcomes Promotional Claims between 2006 and 2012

Author:

Symonds Tara,Hackford Claire,Abraham Lucy

Publisher

Elsevier BV

Subject

Public Health, Environmental and Occupational Health,Health Policy

Reference14 articles.

1. A review of patient-reported outcome labels in the United States: 2006-2010;Gnanasakthy;Value Health,2012

2. FDA Actions against misleading or unsubstantiated economic and quality of life promotional claims: an analysis of warning letters and notices of violation;Stewart;Value Health,2002

3. Guidance for Industry: Patient Reported Outcome Measures: Use in Medical Product Development to Support Labelling Claims. Silver Spring, MD: Food and Drug Administration, 2009. Available from: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf. [Accessed March 14, 2014].

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