Briefing Information for the February 26-27, 2009 Meeting of the Risk Communication Advisory Committee to the FDA
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, 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.
Expert and Consumer Evaluation of Consumer Medication Information – 2008 Final Report(PDF - 2.4MB)
- Action Plan for the Provision of Useful Prescription Medicine Information (Keystone Report) (PDF - 115KB) [ARCHIVED]
CDER Guidance: Useful Written Consumer Medication Information (CMI)(PDF - 73KB) 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 - 17KB) 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 - 95KB) Memo to Members: Another Additional Source of Information(PDF - 17KB)