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21 U.S.C. · Food and Drugs
21 U.S.C. § 355d

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

Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
Title 21 U.S.C. ● ACTIVE Primary Source Ch. 9
Statutory Text

21 U.S.C. § 355d — Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part A - Drugs and Devices Sec. 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers From the U.S. Government Publishing Office, www.gpo.gov

§355d. Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers

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.

(June 25, 1938, ch. 675, §505C, as added Pub. L. 110–85, title IV, §403, Sept. 27, 2007, 121 Stat. 875; amended Pub. L. 112–144, title V, §509(c), July 9, 2012, 126 Stat. 1049; Pub. L. 115–52, title V, §505(f), Aug. 18, 2017, 131 Stat. 1047.)

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.

Source: uscode.house.gov — public domain Official Source ↗
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BS-USC21-SEC-162747
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STATUTE / FEDERAL-CODE-SECTION
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boisestandard.org
Citation
21 U.S.C. § 355d
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Federal — United States
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c7f3b973bad8ce6a...
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The statutory text of 21 U.S.C. § 355d is reproduced from the official United States Code as published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov).
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← 21 U.S.C. § 355c1 21 U.S.C. § 355e →
Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
21 U.S.C. § 30121 U.S.C. § 32121 U.S.C. § 321a21 U.S.C. § 321b21 U.S.C. § 321c21 U.S.C. § 321d21 U.S.C. § 33121 U.S.C. § 33221 U.S.C. § 33321 U.S.C. § 333a21 U.S.C. § 33421 U.S.C. § 33521 U.S.C. § 335a21 U.S.C. § 335b21 U.S.C. § 335c21 U.S.C. § 33621 U.S.C. § 33721 U.S.C. § 337a21 U.S.C. § 34121 U.S.C. § 34221 U.S.C. § 34321 U.S.C. § 343121 U.S.C. § 343221 U.S.C. § 343321 U.S.C. § 343a21 U.S.C. § 34421 U.S.C. § 34521 U.S.C. § 34621 U.S.C. § 346a21 U.S.C. § 346b
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