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2012 U.S. Code
Title 21 - Food and Drugs
Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT (§§ 301 - 399f)
Subchapter V - DRUGS AND DEVICES (§§ 351 - 360ddd-2)
Part A - Drugs and Devices (§§ 351 - 360n-1)
Section 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers

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Publication TitleUnited States Code, 2012 Edition, Title 21 - FOOD AND DRUGS
CategoryBills and Statutes
CollectionUnited States Code
SuDoc Class NumberY 1.2/5:
Contained WithinTitle 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
Containssection 355d
Date2012
Laws in Effect as of DateJanuary 15, 2013
Positive LawNo
Dispositionstandard
Source CreditJune 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.
Statutes at Large References121 Stat. 875
126 Stat. 1049
Public Law ReferencesPublic Law 110-85, Public Law 112-144

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Drugs and Devices - 21 U.S.C. § 355d (2012)
§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, 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.)

Amendments

2012—Pub. L. 112–144 inserted “deferral extensions,” after “deferrals,” in section catchline and “neonatology,” after “pediatric ethics,” in text.

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