Science & Research

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

Selected Publications

Advisory Committee Meetings and Workshops

Guidance Documents


Contact FDA

OC-Office of Pediatric Therapeutics

Page Last Updated: 03/22/2018
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