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 Communities L 378/1.
2. Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 12 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use. Official Journal of the European Communities L 378/20.
3. US Food and Drug Administration. Safety and Innovation Act of 2012, Pub L No. 112-144, 126 Stat 993. https://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf. Accessed March 10, 2016.
4. US Food and Drug Administration. Guidance for industry: qualifying for pediatric exclusivity under Section 505A of the Federal Food, Drug and Cosmetic Act, September 1999. http://www.fda.gov/OHRMS/DOCKETS/98fr/980265gd.pdf.
5. US Food and Drug Administration. Qualifying for pediatric exclusivity under Section 505A of the Federal Food, Drug, and Cosmetic Act: frequently asked questions on pediatric exclusivity (505A), The Pediatric “Rule,” and their Interaction. Q1-Q14: Exclusivity. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm077915.htm.