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Pediatric Ethics

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
  • Explore ethical issues raised by pediatric studies required under the Pediatric Research Equity Act or requested under the Best Pharmaceuticals for Children Act

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