ADOLESCENT;
ARTICLE;
AUSTRALIA;
CONSULTATION;
DRUG UTILIZATION;
FOOD AND DRUG ADMINISTRATION;
HEALTH CARE ACCESS;
HUMAN;
INFANT;
LICENSING;
NEW ZEALAND;
NEWBORN;
PRESCHOOL CHILD;
PRIORITY JOURNAL;
SCHOOL CHILD;
UNITED KINGDOM;
UNITED STATES;
AGE FACTORS;
AUSTRALIA;
CHILD;
CHILD, PRESCHOOL;
DRUG APPROVAL;
GREAT BRITAIN;
HUMANS;
INFANT;
INFANT, NEWBORN;
LEGISLATION, DRUG;
LICENSURE;
NEW ZEALAND;
PEDIATRICS;
PHARMACEUTICAL PREPARATIONS;
UNITED STATES;
Trends in accessibility to medicines for children in New Zealand: 1998-2002
Chui J, Tordoff J, Kennedy J, Reith D. Trends in accessibility to medicines for children in New Zealand: 1998-2002. Br J Clin Pharmacol 2004; 57: 322-7.
Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use
Impicciatore P, Choonara I. Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use. Br J Clin Pharmacol 1999; 48: 15-8.
US Food and Drug Administration Centre for Drug Evaluation and Research. Food and Drug Administration Modernisation Act of 1997 - Section III: Pediatric Studies of Drugs. http://www.fda.gov/ cder/guidance/105-115.htm 1997; Accessed 5 March 2004
US Food and Drug Administration. Best Pharmaceuticals for Children Act. http://www.fda.gov/opacom/laws/pharmkids/ contents.html 2002; Accessed 21 January 2004.
US Food and Drug Administration. Update of list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. http://www.fda.gov/ cder/pediatric/peddrugsfinal.htm; Accessed 10 November 2003.
US Food and Drug Administration. The Pediatric Exclusivity Provision - January 2001; Status Report to Congress. http:// www.fda.gov/cder/pediatric/ reportcong01.pdf 2001; Accessed 22 January 2004: 4-7.
US Food and Drug Administration. Approved active moieties to which FDA has granted Pediatric Exclusivity for Pediatric Studies under Section 505A of the Federal Food, Drug and Cosmetic Act. http://www.fda.gov/cder/pediatric/ exgrant.htm. Accessed: 10 November 2003.
Anonymous. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Clinical Investigation of Medicinal Products in the Pediatric Population. http://www.fda.gov/cder/guidance/ 4099FNL.pdf 2000; Accessed 26 January 2004: 9.
WHO Collaborating Centre for Drug Statistics Methodology. ATC/ DDD Index 2004. http://www.whocc.no/atcddd/indexdatabase 2004; Accessed 26 January 2004.
US Food and Drug Administration Center for Drug Evaluation and Research. Paediatric Exclusivity Labeling Changes as of February 6, 2004. http://www.fda.gov/cder/pediatric/labelchange.htm. Accessed 4 April 2004.