Title 21 — Food and DrugsRelease 119-73not60
§355d Internal Committee for Review of Pediatric Plans, Assessments, Deferrals, Deferral Extensions, and Waivers
Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices › § 355d
Summary
The Secretary must form an internal FDA committee to do the work described in sections 355a(f) and 355c(f). The committee must be made of FDA staff with pediatric expertise (including Office of Pediatric Therapeutics) and other medical, scientific, legal, and ethics experts, plus others the Secretary appoints.
Full Legal Text
Title 21, §355d
Food and Drugs — Source: USLM XML via OLRC
The Secretary shall establish an internal committee within the Food and Drug Administration to carry out the activities as described in section 355a(f) and 355c(f) of this title. Such internal committee shall include employees of the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, neonatology, and the appropriate expertise pertaining to the pediatric product under review, such as expertise in child and adolescent psychiatry or pediatric rare diseases, and other individuals designated by the Secretary.
Legislative History
Notes & Related Subsidiaries
Editorial Notes
Amendments
2017—Pub. L. 115–52 inserted “or pediatric rare diseases” after “psychiatry”. 2012—Pub. L. 112–144 inserted “deferral extensions,” after “deferrals,” in section catchline and “neonatology,” after “pediatric ethics,” in text.
Reference
Citations & Metadata
Citation
21 U.S.C. § 355d
Title 21 — Food and Drugs
Last Updated
Apr 5, 2026
Release point: 119-73not60