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.
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Source location: Title 21, Chapter 9, § 355d; chapter-009-federal-food-drug-and-cosmetic-act.md
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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.
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Federal law — U.S. Code and appendices · legal_authorities
§ 355d. Internal committee for review of pedi-
atric plans, assessments, deferrals, deferral
extensions, and waivers
The Secretary shall establish an internal com-
mittee within the Food and Drug Administra-
tion to carry out the activities as described in
sections 355a(f) and 355c(f) of this title. Such in-
ternal committee shall include employees of the
Food and Drug Administration, with expertise
in pediatrics (including representation from the
Office of Pediatric Therapeutics), biopharma-
cology, statistics, chemistry, legal issues, pedi-
atric ethics, neonatology, and the appropriate
expertise pertaining to the pediatric product
under review, such as expertise in child and ado-
lescent psychiatry or pediatric rare diseases,
and other individuals designated by the Sec-
retary.
(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 dis-
eases’’ after ‘‘psychiatry’’.
2012—Pub. L. 112–144 inserted ‘‘deferral extensions,’’
after
‘‘deferrals,’’
in
section
catchline
and
‘‘neonatology,’’ after ‘‘pediatric ethics,’’ in text.
§ 355e. Pharmaceutical security
(a) In general
The Secretary shall develop standards and
identify and validate effective technologies for
the purpose of securing the drug supply chain
against counterfeit, diverted, subpotent, sub-
standard, adulterated, misbranded, or expired
drugs.
(b) Standards development
(1) In general
The Secretary shall, in consultation with
the agencies specified in paragraph (4), manu-
facturers, distributors, pharmacies, and othe