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EU Paediatric Investigation Plans (Pips) Might Harm Children

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1. Adamson PC. Improving the outcome for children with cancer: development of targeted new agents. CA Cancer J Clin. 2015;65: 212-220.10.3322/caac.21273462948725754421Search in Google Scholar

2. A Phase I/II, Multicenter, Open-Label, Dose-Escalation Study Of The Safety And Pharmacokinetics Of Cobimetinib In Pediatric And Young Adult Patients With Previously Treated Solid Tumors. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-004685-25 Accessed 20JAN2017.Search in Google Scholar

3. A Study of Pembrolizumab (MK-3475) in Pediatric Participants With Advanced Melanoma or Advanced, Relapsed, or Refractory PD-L1-Positive Solid Tumors or Lymphoma (MK-3475-051/KEYNOTE-051). https://clinicaltrials.gov/ct2/show/NCT02332668 (Accessed 20JAN2017).Search in Google Scholar

4. A Study to Determine Safety, Tolerability and Pharmacokineticsof Oral Dabrafenib In Children and Adolescent Subjects. https://clinicaltrials.gov/ct2/show/NCT01677741 (Accessed 20JAN2017).Search in Google Scholar

5. Boots I, Sukhai RN, Klein RH, et al. Stimulation programs for pediatric drug research - do children really benefit? Eur J Pediatr. 2007; 166: 849-855.10.1007/s00431-006-0381-zSearch in Google Scholar

6. BRIM-P. A study of Vemurafenib in pediatric patients with stage IIIC or stage IV melanoma harboring BRAFV600 mutations. https://clinicaltrials.gov/ct2/show/NCT01519323 (Accessed 20JAN2017).Search in Google Scholar

7. Chitnis T, Tenembaum S, Banwell B et al. Consensus statement: evaluation of new and existing therapeutics for pediatric multiple sclerosis. Mult Scler. 2012 Jan;18(1):116-2710.1177/135245851143070422146610Open DOISearch in Google Scholar

8. Eichler I, Sala Soriano E. Close collaboration between academia, industry and drug regulators is required in the development of allergen products for specific immunotherapy in children. Allergy 2011: 66: 999-1004.10.1111/j.1398-9995.2011.02582.x21426358Search in Google Scholar

9. EMA website. www.ema.europa.eu (Accessed 20JAN2017)Search in Google Scholar

10. EMA 2004: Evidence of harm from off-label or unlicensed medicines in children. www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004021.pdfSearch in Google Scholar

11. EMA 2011. EMA class waivers, http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/12/WC500119981.pdf (Accessed 20FEB2017).Search in Google Scholar

12. EMA 2010. European Medicines Agency decision P/345/2010 of 20 December 2010 on a class waiver on condition(s) in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/11/WC500011500.pdf. Accessed 20JAN2017 (Accessed 20JAN2017).Search in Google Scholar

13. EMA 2015. European Medicines Agency decision CW/0001/2015 of 23 July 2015 on class waivers, in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council. www.ema.europa.eu/docs/en_GB/document_library/Other/2015/07/WC500190385.pdfSearch in Google Scholar

14. EMA 2015. Better Medicines for Children. www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2009/12/WC500026493.pdfSearch in Google Scholar

15. EMA2016. 10-year Report to the European Commission. General report on the experience acquired as a result of the application of the Paediatric Regulation. http://ec.europa.eu/health//sites/health/files/files/paediatrics/2016_pc_report_2017/ema_10_year_report_for_consultation.pdf. Accessed 20JAN2017 (Accessed 20JAN2017).Search in Google Scholar

16. FDA. Best Pharmaceuticals for Children Act and Pediatric Research Equity Act July 2016. Status Report to Congress. www.fda.gov/downloads/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/UCM509815.pdf (Accessed 20JAN2017).Search in Google Scholar

17. Frattarelli DA, Galinkin JL, Green TP et al. Off-label Use of Drugs in Children. Pediatrics 2014, 133 (3), 563-567.10.1542/peds.2013-406024567009Search in Google Scholar

18. Hilts PJ. Protecting America›s Health: The FDA, Business, and One Hundred Years of Regulation. University of North Carolina Press 2004.Search in Google Scholar

19. Kearns GL, Abdel-Rahman SM, Alander SW et al. Developmental Pharmacology - Drug Disposition, Action, and Therapy in Infants and Children. N Engl J Med. 2003;349(12):1157-1167.10.1056/NEJMra03509213679531Search in Google Scholar

20. Mentzer D. Progress review of the European Paediatric Regulatory Framework after six years of implementation. Int J Pharm. 2014 Aug 5;469(2):240-3.10.1016/j.ijpharm.2014.03.01924613178Search in Google Scholar

21. Phase 2 study of Ipilimumab in children and adolescents (12 to < 18 Years) with previously treated or untreated, unresectable stage III or stage lV malignant melanoma. https://clinicaltrials.gov/ct2/show/NCT01696045.Search in Google Scholar

22. Philip AG. The Evolution of Neonatology. Pediatr Res. 2005 Oct;58(4):799-815.10.1203/01.PDR.0000151693.46655.6615718376Search in Google Scholar

23. Regulation (EC) No 1901/2006 Of The European Parliament And Of The Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union, 27.12.2006, L 378/1 - L 278/19 http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdfpdf (Accessed 20JAN2017).Search in Google Scholar

24. Rocchi F, Paolucci P, Ceci A, Rossi P. The European paediatric legislation: benefits and perspectives. Italian Journal of Pediatrics 2010, 36:56 Link: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2933611/pdf/1824-7288-36-56.pdf (Accessed 20JAN2017).10.1186/1824-7288-36-56293361120716337Search in Google Scholar

25. Rose K. Pediatric Pharmaceutical Legislation in the USA and EU and Their Impact on Adult and Pediatric Drug Development. In: Bar-Shalom D & Rose K: Pediatric Formulations - A Roadmap, AAPS & Springer, 2014: chapter 28, pp. 405-420.10.1007/978-1-4899-8011-3_28Search in Google Scholar

26. Rose K. European Union Pediatric Legislation Jeopardizes Worldwide, Timely Future Advances in the Care of Children With Cancer. Clinical Therapeutics 2014, 36 (2), 163-177.10.1016/j.clinthera.2014.01.00924529288Open DOISearch in Google Scholar

27. Rose K. New Drugs For Rare Diseases in Children. Clin Ther 2017, in press.10.1016/j.clinthera.2017.01.01228161117Search in Google Scholar

28. Rose K & Happle R. The Impact of Regulation on Pediatric Psoriasis Drug Approvals: The Challenge of the European Union (EU) Pediatric Investigation Plans. Pediatric Dermatology 2017, in press.10.1111/pde.1309728523878Search in Google Scholar

29. Rose K & Kopp MV. Pediatric investigation plans for specific immunotherapy: Questionable contributions to childhood health. Pediatr Allergy Immunol. 2015 Dec;26(8):695-701.10.1111/pai.1250026495999Search in Google Scholar

30. Rose K & Mueller T. Children with Multiple Sclerosis Should Not Become Therapeutic Hostages. Ther Adv Neurol Disord 2016, 9(5) 389-395.10.1177/1756285616656592499478527582894Open DOISearch in Google Scholar

31. Rose K & Walson PD. The contributions of the European Medicines Agency and its pediatric committee to the fight against childhood leukemia. Risk Manag Healthc Policy. 2015 Nov 5;8:185-205.10.2147/RMHP.S63029464023026604845Search in Google Scholar

32. Rose K & Walson PD. Do the European Medicines Agency (EMA) Decisions Hurt Pediatric Melanoma Patients? Clin Ther 2017, in press.10.1016/j.clinthera.2017.01.00928159363Open DOISearch in Google Scholar

33. Rose K & Senn S. Drug development: EU paediatric legislation, the European Medicines Agency and its Paediatric Committee - adolescents’ melanoma as a paradigm. Pharmaceutical Statistics 2014; 13(4): 211-213.10.1002/pst.162324903307Open DOISearch in Google Scholar

34. Shim KS. Pubertal growth and epiphyseal fusion. Ann Pediatr Endocrinol Metab. 2015 Mar;20(1):8-12. 10.6065/apem.2015.20.1.8439727625883921Search in Google Scholar

35. Shirkey H. Therapeutic Orphans. Pediatrics 1999 Sep;104(3 Pt 2):583-584.10.1542/peds.104.S3.583Search in Google Scholar

36. To Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors https://clinicaltrials.gov/ct2/show/NCT01962103 (Accessed 20JAN2017).Search in Google Scholar

37. Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards. Acta Paediatr 1999, 88: 965-968.10.1111/j.1651-2227.1999.tb00191.xSearch in Google Scholar

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Medicine, Basic Medical Science, Immunology, Clinical Medicine, other