§ 355d. Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
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/usc/title-21/section-355dA research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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.)
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- Public Law 112–144To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes
- Public Law 110–85To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes
- Public Law 115–52To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes
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- Sec. 3Improving the timeliness of pediatric studies
- Sec. 505Additional provisions on development of drugs and biological products for pediatric use
- Sec. 505Additional provisions on development of drugs and biological products for pediatric use
- Sec. 505Additional provisions on development of drugs and biological products for pediatric use
- Sec. 3Improving the timeliness of pediatric studies
- Sec. 2Federal U.S. pharmaceutical supply chain mapping
- Sec. 4U.S. pharmaceutical supply chains mapping
- Sec. 1083Mapping America's Pharmaceutical Supply
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- June 25, 1938, ch. 675, § 505C
- Pub. L. 110–85, title IV, § 403
- 121 Stat. 875
- Pub. L. 112–144, title V, § 509(c)
- 126 Stat. 1049
- 131 Stat. 1047
- Pub. L. 112–144
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§ 355d
Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
Bills×11
U.S.C.×8
Stat.×5
Stat. Comp.×4
Pub. L.×2
Fed. Reg.×1
ActJune 25, 1938, ch. 675, § 505C
Pub. L.Pub. L. 110–85, title IV, § 403
Stat.121 Stat. 875
Pub. L.Pub. L. 112–144, title V, § 509(c)
Stat.126 Stat. 1049
Cites 8 · showing 6Cited by 31 across 6 sources