1. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union, 27.12.2006, L 378/1 - L 278/19. http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf . Accessed 26 May 2017.
2. Rose K. Pediatric pharmaceutical legislation in the USA and EU and their impact on adult and pediatric drug development. In: Bar-Shalom D, Rose K, editors. Pediatric formulations—a roadmap. AAPS & Springer: New York; 2014. p. 405–20 (Chapter 28).
3. Mentzer D. Progress review of the European Paediatric Regulatory Framework after six years of implementation. Int J Pharm. 2014;469:240–3.
4. Hilts PJ. Protecting America’s health: the FDA, business, and one hundred years of regulation. Chapel Hill: University of North Carolina Press; 2004.
5. Kefauver-Harris amendments revolutionized drug development. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm322856.htm . Accessed 26 May 2017.