1. Hamburg MA. Remarks at the National Press Club Speaker Luncheon. October 6, 2010. http://www.fda.gov/NewsEvents/Speeches/ucm229195.htm (accessed January 5, 2011).
2. Food and Drug Administration. Strategic priorities 2011–2015: responding to the public health challenges of the 21st century (draft). http://www.fda.gov/downloads/AboutFDA/ReportManualsForms/Reports/StrategicActionPlan/UCM226907.pdf (accessed January 5, 2011).
3. Food and Drug Administration. The Sentinel Initiative: national strategy for monitoring medical product safety. 2008. http://www.fda.gov/downloads/Safety/FDAsSentinellnitiative/UCM124701.pdf (accessed February 12. 2011).
4. Food and Drug Administration. The Sentinel Initiative: access to electronic healthcare data for more than 25 million lives: achieving FDAAA Section 905 goal one. http://www.fda.gov/downloads/Safety/FDAsSentinellnitiative/UCM233360.pdf (accessed February 12, 2011).
5. Institute of Medicine of the National Academies. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington. DC: National Academies Press; 2007. (Report released September 2006, published in book form in 2007: see also http://iom.edu/Reports/2006/The-Future-of-Drug-Safety-Promoting-and-Protecting-the-Health-of-the-Public.aspx. accessed February 12, 2011.)