Risk evaluation and mitigation strategy assessments: Social science methodologies to assess goals related to knowledge

Author:

Andrews Elizabeth,Davis Kimberly,DiBenedetti Dana,Forsyth Barbara,Gilsenan Alicia,Hollis Kelly,Lewis Sandy,Price Mark,Tennis Patricia,Zografos Laurie

Publisher

RTI Press

Reference34 articles.

1. 1. US Department of Health and Human Services. Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Guidance for industry. Development and use of risk minimization action plans [Internet]. 2005 March [cited 2013 August 28]. Available from: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126830.pdf

2. 2. Food and Drug Administration. Risk Evaluation and Mitigation Strategy (REMS) Assessments: Social Science Methodologies to Assess Goals Related to Knowledge: public workshop [Internet]. 2012 June [cited 2013 August 28]. Available from: http://www.fda.gov/Drugs/NewsEvents/ucm292337.htm

3. 3. US Department of Health and Human Services. Food and Drug Administration. Docket No. FDA-2012-N-0408. Risk evaluation and mitigation strategy assessments: social science methodologies to assess goals related to knowledge. Issue paper. 2012 June 7. [cited 2013 August 28]. Available from: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM301966.pdf

4. A patient follow-up survey programme for alosetron: assessing compliance to and effectiveness of the risk management programme;Miller;Alimentary Pharmaco Therap,2006

5. The relationship between dosing of alosetron and discontinuation patterns reported by patients participating in a follow-up programme;Tennis;Aliment Pharmacol Ther,2007

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