21 U.S.C. § 355D
Section 355d · Internal committee for review of pediatric plans, assessments, deferrals, and waivers
This is § 505c of the All Kids Act
Amended 4 times on record
Applied in 1 court decisions — leading case Amgen Inc. v. Hargan (2018)
Most recently applied in Amgen Inc. v. Hargan (January 2018)
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.
Editorial notes U.S. Code · Office of the Law Revision Counsel
Amendments
2017—Pub. L. 115–52 inserted “or pediatric rare diseases” after “psychiatry”.
2012—Pub. L. 112–144 inserted “deferral extensions,” after “deferrals,” in section catchline and “neonatology,” after “pediatric ethics,” in text.