21 U.S.C. § 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.
Notes of Decisions
Cited in 2
cases, 2018–2018 · leading case: Amgen Inc. v. Hargan, 285 F. Supp. 3d 351 (D.C. Cir. 2018).
Amgen Inc. v. Hargan, 285 F. Supp. 3d 351 (D.C. Cir. 2018). “" 21 U.S.C. § 355d. When issued, the written request asks the sponsor to "conduct pediatric studies" within a certain timeframe and to "propose pediatric labeling resulting from such studies.”
Amgen Inc. v. Price (D.D.C. 2018). “When issued, the written request asks the sponsor to “conduct pediatric studies” within a certain timeframe and to “propose pediatric labeling resulting from such studies.” 21 U.S.C. § 355a(d)(1)(A). The written request “serves as a yardstick against which the sponsor’s…”
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