Browse Arkansas Code titles and sections
21 U.S.C. § 355d — Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
Federal law — U.S. Code and appendices · legal_authorities
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.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355d
Stored review status: release_metadata_unconfirmed. A text match is a research starting point; applicability is not established.
Original supplied file — preserved unchanged
Download original Markdown file
File SHA-256: 7985ea2568dc362394bd507738dcaeb53c5e67766a45003e78266f19a12465b7. The original may include catalog metadata, neighboring provisions, or embedded records outside this collection's scope. Search shows only the selected federal record. Historical editions and unverified snapshots are not a statement of current law.
Authority boundary: historical or unconfirmed source not current law verified.
Open the recorded source website ↗
Record provenance
Stable record: federal_law:legal_authorities:record_usc_243be77b44254c9705719f8d
Source file: Laws/federal/codes/united-states-code/title-21/section-355d-internal-committee-for-review-of-pediatric-plans-assessments-deferrals-d--25cedbecd8.md
Pages: Not recorded – Not recorded
Passage SHA-256: 08b030c39e0a849e5798cbfdb3fcc76c2da9884d1eed38b0afcb1fd7358b0f1f
Source location: Title 21, Chapter 9, § 355d; chapter-009-federal-food-drug-and-cosmetic-act.md
Stored source content
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.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** As used in this section, the term “pediatric studies” or “studies” means at least one clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies.
**(b) Market exclusivity for new drugs**
(1) **In general** — Except as provided in paragraph (2), if, prior to approval of an application that is submitted under [section 355(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b/1&num=0&edition=prelim), the Secretary determines that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with subsection (d)(4)—
(A)
(i)
(I) the period referred to in subsection (c)(3)(E)(ii) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), and in subsection (j)(5)(F)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355a
Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) New drugs and biological products**
(1) **In general**
(A) *General requirements* — Except with respect to an application for which subparagraph (B) applies, a person that submits, on or after September 27, 2007, an application (or supplement to an application) for a drug—
(i) under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration; or
(ii) under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration,
shall submit with the application the assessments described in paragraph (2).
(B) *Certain molecularly targeted cancer indications* — A person that submits, on or after the date that is 3 years after August 18, 2017, an original application for a new active ingredient under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), shall submit with the application reports on the investigation described in paragraph (3) if the drug or biological product that is the subject of the application is—
(i) intended for the treatment of an adult cancer; and
(ii) directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.
(2) **Assessments**
(A) *In general* — The assessments referred to in
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355c
Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
Page 260
TITLE 21—FOOD AND DRUGS
§ 355d
reports, including recommendations therein, regarding
the topics addressed in the reports under this section,
including with respect to—
‘‘(A) improving public access to information from
pediatric studies conducted under such sections 355a
and 355c of this title; and
‘‘(B) improving the timeliness of pediatric studies
and pediatric study planning under such sections 355a
and 355c of this title.’’
Statutory Notes and Related Subsidiaries
RULE OF CONSTRUCTION
Nothing in amendment by Pub. L. 115–52 to limit the
authority of the Secretary of Health and Human Serv-
ices to issue written requests under section 355a of this
title or section 262(m) of Title 42, The Public Health
and Welfare, or to negotiate or implement amendments
to such requests proposed by applicants, see section
504(e) of Pub. L. 115–52, set out as a note under section
355c of this title.
DEFINITION OF ‘‘SECRETARY’’
The term ‘‘Secretary’’ as used in this section means
the Secretary of Health and Human Services, see sec-
tion 503 of Pub. L. 112–144, set out as a note under sec-
tion 355a of this title.
§ 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 revi
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 355d
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.