What the paediatricians need - The launch of paediatric research in Europe

European Journal of Pediatrics

Volumn 164, Issue 5, 2005, Pages 263-265

  Ramet, José ^a  

^a UNIVERSITY HOSPITAL BRUSSELS   (Belgium)

Author keywords

European Union; Medicines for children; Off label use; Paediatric drugs; Pharmaceutical paediatric research

Indexed keywords

DRUG;

CHILD HEALTH CARE; DRUG DOSE REGIMEN; DRUG INDUSTRY; DRUG LABELING; DRUG MARKETING; DRUG RESEARCH; DRUG SCREENING; EUROPE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE NEED; HUMAN; MEDICAL RESEARCH; MEDICINE; PRIORITY JOURNAL; PROCESS DEVELOPMENT; RISK BENEFIT ANALYSIS; SHORT SURVEY;

CHILD; DRUG EVALUATION; DRUG LABELING; EUROPE; GOVERNMENT REGULATION; HUMANS; PEDIATRICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 18044375992     PISSN: 03406199     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00431-005-1633-z     Document Type: Short Survey

References (12)

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4. European Commission (2002) Pharmaceuticals: regulatory framework and market authorizations. Better medicines for children - proposed regulatory action on paediatric medicinal products. Consultation document, February 28th http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2002/feb/cd_pediatrics_en.pdf (accessed January 26, 2004)
5. European Commission (2003) Directorate-General for Research. Towards a European Research Area Science, Technology and Innovation. Key Figures 2003-2004, pp 43-44
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7. Gregg (2003) Pediatric Research Equity Act of June 27 (legislative day, June 26), from the Committee on Health, Education, Labor, and Pensions. US Senate report 108-84, p 3 http://frwebgate.access.gpo.gov/cgi-in/getdoc.cgi? dbname=108_cong_ reports&docid=f:sr084.108.pdf (accessed January 26, 2004)
8. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (2000) Official Journal of the European Communities L18, pp 1-5
9. Smith, RN (2002) 5th EMEA/IFAPP Conference. Meeting report: clinical studies at extremes of age. Int J Pharm Med 16: 49-56
10. The Pediatric Exclusivity Provision (2001) Status Report to Congress - Department of Health and Human. January Services - US Food and Drug Administration, p 12 http://www.fda.gov/cder/pediatric/reportcong01.pdf (accessed January 26, 2004)
11. US Food and Drug Administration (2003) Center for Drug Evaluation and Research. Paediatric Exclusivity Labelling Changes as of August 22 http://www.fda.gov/cder/pediatric/labelchange.htm (accessed January 26, 2004)
12. US Food and Drug Administration (2003) Department of Health and Human Services. FDA Statement. Statement of the FDA Commissioner Mark B. McClellan, M.D., Ph.D., on the signing of the Pediatric Research Equity Act of December 3 http://www.fda.gov/bbs/topics/NEWS/2003/NEW00989.html (accessed January 26, 2004)