FDA Advisory Committees - FDA Office of the Commissioner (OC) - Pediatric Advisory Committee (PEDAC)

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Pediatric Advisory Committee (PEDAC)

PEDAC advises and makes recommendations to the FDA Commissioner regarding:

  • Pediatric research conducted under the Public Health Service Act (sections 351, 409I, & 499) and the Federal Food, Drug, & Cosmetic Act (sections 501, 502, 505, 505A, and 505B).
  • Identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions
  • The ethics, design, and analysis of clinical trials related to pediatric therapeutics.
  • Pediatric labeling disputes as specified in sections 3 and 5 of the Best Pharmaceuticals for Children Act (BPCA) (Public Law 107-109),
  • Adverse event reports for drugs granted-pediatric exclusivity and any safety issues that may occur as specified in BPCA (section 17).
  • Any other pediatric issue or pediatric labeling dispute involving FDA-regulated products
  • Research involving children as subjects as specified in 21 CFR 50.54, and
  • Any other matter involving pediatrics for which FDA has regulatory responsibility.

Subcommittees:

  • Pediatric Ethics Subcommittee
  • Neonatology Subcommittee of the Pediatric Advisory Committee

FDA Committee Website