4. FDA Approach to Pediatric Testing

  1. Alan M. Hoberman2 and
  2. Elise M. Lewis3
  1. Robert E. Osterberg

Published Online: 11 JAN 2012

DOI: 10.1002/9781118168226.ch4

Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices

Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices

How to Cite

Osterberg, R. E. (2012) FDA Approach to Pediatric Testing, in Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices (eds A. M. Hoberman and E. M. Lewis), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118168226.ch4

Editor Information

  1. 2

    Research Department, Charles River Laboratories Preclinical Services, Horsham, PA, USA

  2. 3

    Elise M. Lewis, Reproductive and Neurobehavioral Toxicology, Charles River Preclinical Services, Horsham, PA, USA

Author Information

  1. Aclairo Pharmaceutical Development Group Inc, Vienna, VA, USA

Publication History

  1. Published Online: 11 JAN 2012
  2. Published Print: 27 JAN 2012

ISBN Information

Print ISBN: 9780470448618

Online ISBN: 9781118168226

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Keywords:

  • pediatric, FDA rule “1994 Rule” ensuring new drugs with pediatric labelings;
  • BPCA, and FD&C Act, for prescription drugs and medical devices;
  • drug prescribers to understand biologicals, Animal Teratogens May Not Be Human Teratogens

Summary

This chapter contains sections titled:

  • Introduction

  • History of Drug Regulation

  • Drugs, Children, and Legislation

  • Best Pharmaceuticals for Children Act

  • Toxicities in Children

  • FDA's Approach to Nonclinical Pediatric Testing

  • The International Conference on Harmonisation (ICH)

  • The European Union (EU) and the European Medicines Agency (EMA) Approach to Pediatric Testing

  • Conclusion

  • References