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

Journal of the American Academy of Child and Adolescent Psychiatry

Volumn 48, Issue 11, 2009, Pages 1056-1059

  Upadhyaya, Himanshu P ^a   Gault, Laura ^a   Allen, Albert J ^a  

^a ABBOTT LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG APPROVAL; DRUG INFORMATION; DRUG MARKETING; DRUG SCREENING; EDITORIAL; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL;

ADOLESCENT; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; CROSS-CULTURAL COMPARISON; DRUG APPROVAL; DRUG DISCOVERY; DRUG INDUSTRY; DRUG TOXICITY; HUMANS; MENTAL DISORDERS; PSYCHOTROPIC DRUGS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 71149104076     PISSN: 08908567     EISSN: 15275418     Source Type: Journal    
DOI: 10.1097/CHI.0b013e3181baec67     Document Type: Editorial

References (7)

1. Allen A.J. Commentary by a child psychiatrist in industry on the assessment of drug safety. J Child Adolesc Psychopharmacol 17 (2007) 288-291
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 J.J. Understanding Pharma: A Primer on How Pharmaceutical Companies Really Work (2007), Pharmaceutical Institute, Raleigh, NC
6. Ernest T.B., Elder D.P., Martini L.G., Roberts M., and Ford J.L. Developing paediatric medicines: identifying the needs and recognizing the challenges. J Pharm Pharmacol 59 (2007) 1043-1055
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.