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21 U.S.C. § 355d — Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers

submitted 88 years ago by Pub. L. 110-85 to r/title-21-FOOD-AND-DRUGS · 90 words · no verdicts yet

in plain englishAI-generated · not legal advice

The Secretary must create an internal FDA committee for pediatric drug reviews. It handles plans, assessments, deferrals, extensions, and waivers under sections 355a and 355c. Members must have expertise in pediatrics, biopharmacology, statistics, chemistry, law, ethics, and neonatology, plus experts the Secretary picks.

The Secretary of Health and Human Services must set up a committee inside the Food and Drug Administration. This committee handles the work described in sections 355a(f) and 355c(f) — reviewing pediatric study plans, assessments, deferrals, deferral extensions, and waivers. The committee must include FDA employees with expertise in several areas: pediatrics (including someone representing the Office of Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, and neonatology. It must also include people with whatever expertise fits the specific pediatric product under review — for example, expertise in child and adolescent psychiatry or in pediatric rare diseases. Finally, the Secretary can add other individuals to the committee as well.
the actual law source: uscode.house.gov ↗public domain

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 credit: (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.)

history & why it existsrecord from the source credit
  • 1938Enacted · Pub. L. 110-85 · 121 Stat. 875
  • 2012Amended · Pub. L. 112-144 · 126 Stat. 1049
  • 2017Amended · Pub. L. 115-52 · 131 Stat. 1047

A history note hasn’t been published yet. The record shows enactment by Pub. L. 110-85 on 1938-06-25.

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