Nihon Shoni Arerugi Gakkaishi. The Japanese Journal of Pediatric Allergy and Clinical Immunology
Online ISSN : 1882-2738
Print ISSN : 0914-2649
ISSN-L : 0914-2649
ACTIVITIES PROMOTING THE PEDIATRIC CLINICAl TRIALS AND THE DRUG DEVELOPMENT IN UNITED STATES AND EUROPEAN UNION
Nao Tsuchida
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2009 Volume 23 Issue 1 Pages 83-90

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Abstract
Off-label use in children is common throughout the world and a key issue. Activities resolving these issues have been stepped forward in the U.S. and EU since the 1990s. It have been tried various expedients to achieve the purpose. Because of need for facilitating the development of pediatric trials of therapies for HIV, eventually the following laws were legislated. These are referred to children in whole or in part.
 U.S.: FDA Modernization Act (1997)
  Best Pharmaceuticals for Children Act (2002)
  Pediatric Research Equity Act (2003)
  FDA Amendments Act of 2007
 EU: Paediatric Regulation (2007)
These approaches would promote the pediatric clinical trials and the drug development in the U.S. and EU. We have to work together cooperatively with the U.S. and EU.
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© 2009 Japanese Society of Pediatric Allergy and Clinical Immunology
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