Challenges and Opportunities in Bringing New Medications to Market for Pediatric Patients

References 

1. Allen AJ . Commentary by a child psychiatrist in industry on the assessment of drug safety . J Child Adolesc Psychopharmacol . 2007;17:288–291
   • CrossRef
2. International Conference on Harmonization (ICH) Guidance Documents . http://www.fda.gov/RegulatoryInformation/Guidances/ucm122049.htm Accessed July 29, 2009.
3. International Conference on Harmonisation . http://www.ich.org/cache/compo/276-254-1.html Accessed July 29, 2009.
4. Prescription Drug User Fee Act (PDUFA) . http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm Accessed July 29, 2009.
5. Campbell JJ . Understanding Pharma: A Primer on How Pharmaceutical Companies Really Work . Raleigh, NC: Pharmaceutical Institute; 2007;
6. Ernest TB , Elder DP , Martini LG , Roberts M , Ford JL . Developing paediatric medicines: identifying the needs and recognizing the challenges . J Pharm Pharmacol . 2007;59:1043–1055
   • CrossRef
7. Woodcock J. Statement by Janet Woodcock (MD) Director of Center for Drug Evaluation and Research, Food and Drug Administration, Department of Health and Human Services before the Committee on Health, Education, Labor and Pensions, 8th May, 2001.