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U.S. Department of Health and Human Services

Science & Research

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Pediatric Ethics

Provides information on ethical issues raised in the development and use of FDA-regulated products in infants, children and adolescents


Our Mission:
To assure that all FDA-regulated clinical trials enrolling children are scientifically sound and ethically appropriate
 

What we do: 

  • Provide a pediatric ethics consultation service available upon request to anyone within the FDA related to any ethical issue in FDA-regulated pediatric product development
  • Assess reports of potential pediatric ethics violations in FDA-regulated research from external stakeholders
  • Public speaking at internal and external events by invitation, and training of FDA staff and external stakeholders on ethical issues in FDA-regulated pediatric product development
  • To explore ethical issues raised by pediatric studies required under the Pediatric Research Equity Act or requested under the Best Pharmaceuticals for Children using OPT’s custom databases

 

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Selected Presentations

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Selected Publications

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Advisory Committee Meetings and Workshops

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Guidance Documents

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Regulations

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Contact FDA

301-796-8659
OC-Office of Pediatric Therapeutics