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21 U.S.C. § 355d

Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers

United States · Title 21 — FOOD AND DRUGS · Status: effective

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21 U.S.C. § 355d, Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454239
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The Secretary shall establish an internal committee within the Food and Drug Administration to carry out the activities as described in sections 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

The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.

  • Enacted byPub. L. 110-85(H.R. 3580)2007-09-27
    Food and Drug Administration Amendments Act of 2007
    House: 405–7Senate: no recorded tally
  • Amended byPub. L. 112-144(S. 3187)2012-07-09
    Food and Drug Administration Safety and Innovation Act
    House: no recorded tallySenate: 96–1
  • Amended byPub. L. 115-52(H.R. 2430)2017-08-18
    FDA Reauthorization Act of 2017
    House: no recorded tallySenate: 94–1