§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.

(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 diseases" after "psychiatry".

2012-Pub. L. 112–144 inserted "deferral extensions," after "deferrals," in section catchline and "neonatology," after "pediatric ethics," in text.