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 Risk Communication Advisory Committee + members of Drug Safety and Risk Management Advisory Committee

February 26 and 27, 2009

BRIEFING INFORMATION

FDA

Expert and Consumer Evaluation of Consumer Medication Information –
2008 Final Report (pdf)

Action Plan for the Provision of useful Prescription Medicine Information
(Keystone Report)  (pdf)

CDER Guidance: Useful Written Consumer Medication Information (CMI) (pdf)

Memo to Members:  Optional Additional Information Relevant to February 26-27 Meeting of Risk Communication Advisory Committee with members of Drug Safety and Risk Management Advisory Committee (pdf)

Schwartz LM, Woloshin S and Welch HG.  The Drug Facts Box:  Providing Consumers with Simple Tabular Data on Drug Benefit and Harm. 
Medical Decision Making.  2007; 27: 655-662

Raynor DK, Blenkinsopp A, et al.  A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines, Health Technology Assessment HTA NHS R&D HTA Programme
Executive Summary:  Health Technology Assessment 2007; Vol. 11: No. 5  (pdf)

Raynor DK, Svarstad B, et al. Consumer Medication Information in the United States, Europe, and Australia:  A Comparitive Evaluation.  Journal of the American Pharmacists Association. 2007; 47(6): 717-724.

Knapp P, Raynor DK, and Berry DC.  Comparison of Two Methods of Presenting Risk Information to Patients about the Side Effects of Medicines. 
Quality and Safety in Healthcare.  2004; 13: 176-180.

Memo to Members:  Another Additional Source of Information ( pdf)

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