1. US Food and Drug Administration (2012) Centre for Drug Evaluation and Research. Guidance drug safety information – FDA’s Communication to Public. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM295217.pdf . Accessed 22 May, 2013
2. Madre LK, Califf RM, Reynolds RF et al (2006) Views from Academia, Industry, and Regulatory Agencies. In: Strom BL, Kimmel SE (eds) Textbook of pharmacoepidemiology. John Wiley & Sons, Chichester, pp 63–88
3. Wysowski DK, Swartz L (2005) Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reported suspected reactions. Arch Inter Med 165(12):1363–1369
4. Moore TJ, Singh S, Furberg CD (2012) The FDA and new safety warnings. Arch Intern Med 172(1):78–80
5. Ahamd SR, Marks NS, Goetsch RA (2006) Spontaneous reporting in the United States. In: Strom BL, Kimmel SE (eds) Textobook of pharmacoepidemiology. John Wiley & Sons, Chichester, pp 91–116