1. The European paediatric initiative: History of the Paediatric Regulation (EMEA/17967/04 Rev 1)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/09/WC500003693.pdf/.
2. Off-label Uses of Drugs in Children;Blumer;Pediatrics,1999
3. Guidance for Industry: The Content and Format for Pediatric Use Supplementshttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071957.pdf/.
4. History of Pediatric Studies, Rule, Legislation and Litigationhttp://www.bio.org/reg/action/pedhist.asp.