§ 355d. Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Pediatric Research Equity Act of 2007

   Pub. L. 110–85 title IV § 403 · 121 Stat. 823

   Enacted · 21 U.S.C. § 355d

   June 25, 1938, ch. 675, § 505C, as added Pub. L. 110–85, title IV, § 403, Sept. 27, 2007, 121 Stat. 875

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 505C, as added Pub. L. 110–85, title IV, § 403, Sept. 27, 2007, 121 Stat. 875

   Enacted provision · exact public law section
   SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE.   Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505B the following: “SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, AND WAIVERS.   “The Secretary shall establish an internal committee within the Food and Drug Administration to carry out the activities as described in sections 505A(f) and 505B(f). 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, and the appropriate expertise pertaining to the pediatric product under review, such as expertise in child and adolescent psychiatry, and other individuals designated by the Secretary.” .

2. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 title V § 509(c) · 126 Stat. 993

   Inserted · 21 U.S.C. § 355d

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

   Source evidence

   Code amendment note
   Pub. L. 112–144 inserted “deferral extensions,” after “deferrals,” in section catchline and “neonatology,” after “pediatric ethics,” in text.

   Enacted provision · exact public law section
   (c) Internal Committee for Review of Pediatric Plans, Assessments, Deferrals, Deferral Extensions, and Waivers.— Section 505C (21 U.S.C. 355d) is amended— (1) in the section heading, by inserting “deferral extensions,” after “deferrals,”; and (2) by inserting “neonatology,” after “pediatric ethics,”.

3. 2017

   FDA Reauthorization Act of 2017

   Pub. L. 115–52 title V § 505(f) · 131 Stat. 1005

   Inserted · 21 U.S.C. § 355d

   Pub. L. 115–52 inserted “or pediatric rare diseases” after “psychiatry”

   Source evidence

   Code amendment note
   Pub. L. 115–52 inserted “or pediatric rare diseases” after “psychiatry”.

   Enacted provision · exact public law section
   (f) Internal Committee.— Section 505C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) is amended by inserting “or pediatric rare diseases” after “psychiatry”.

3 of 3 references resolved to an enrolled provision