1. Eichler H-G, Bloechl-Daum B, Abadie E, et al. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. Nat Rev Drug Discov 2010; 9: 277–91
2. Unger EF. Weighing benefits and risks: the FDA’s review of prasugrel. N Engl J Med 2009; 361: 942–5
3. Breckenridge A. Regulatory challenges, reimbursement, and risk-benefit assessment. Clin Pharmacol Ther 2010; 88 (2): 153–4
4. US Food andDrugAdministration, Center forDrug Evaluation and Research. Guidance for industry: premarketing risk [online]. Available from URL: http://www.fda.gov/CDER/guidance/6357fnl.htm. [Accessed 2010 Oct 22]
5. Department of Health and Human Services. Food and Drug Administration [docket no. FDA-2008-N-0174]. Identification of drug and biological products deemed to have risk evaluation and mitigation strategies for purposes of the Food and Drug Administration Amendments Act of 2007. Federal Register/ Vol. 73, No. 60/Thursday, March 27/Notices [online]. Available from URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf [Accessed 2011 Mar 16]