References
- Making sure the EU paediatric regulation does its job. Ager. B. Reg. Affairs J.20(5), 277 (2009).
- Li JS, Eisenstein EL, Grabowski HG et al. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA297(5), 480–488 (2007).
- MichauxG. Paediatric exclusivities in Europe: a quest for the Grail? Food Drug Law J.64(4), 631–662 (2009).
Websites
- Best Pharmaceuticals for Children Act. FDA website www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049867.htm (Accessed 21 April 2010)
- Retrospective review of information submitted and actions taken in response to PREA 2003 www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM197636.pdf (Accessed 21 April 2010)
- Regulation of the European Parliament and of the Council on medicinal products for paediatric use. Regulation (EC) No 1901/2006 http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf
- Make medicines child size. WHO website www.who.int/childmedicines/en (Accessed 21 April 2010)
- EMEA strategy paper: acceptance of clinical trials conducted in third world countries, for evaluation in Marketing Authorisation Applications www.ema.europa.eu/Inspections/docs/22806708en.pdf (Accessed 21 April 2010)