1. The Use of Food and Drug Administration Approved Medications for Unlabeled (Off-Label) Uses
2. Controlling Off-Label Medication Use
3. Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals
4. Regulatory Information. Food and Drug Administration. “Off-Label” and investigational use of marketed drugs, biologics, and medical devices—information sheet guidance for institutional review boards and clinical investigators. Updated August 2011. Available at: http://www.fda.gov/Regulatory-Information/Guidances/ucm126486.htm. Accessed January 23, 2012.
5. Drug Safety Update. Medicines and Health Care products Regulatory Agency. Off-label or unlicensed use of medicines: prescribers’ responsibilities, updated April 2009. Available at: http://www.mhra.gov.uk/Safetyinformation/DrugSafety-Update/CON087990. Accessed January 23, 2012.