21 U.S.C. § 393a
Office of Pediatric Therapeutics
United States · Title 21 — FOOD AND DRUGS · Status: effective
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- Citation
- 21 U.S.C. § 393a, Office of Pediatric Therapeutics, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454497
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Full text
The Secretary of Health and Human Services shall establish an Office of Pediatric Therapeutics within the Food and Drug Administration.
The Office of Pediatric Therapeutics shall be responsible for coordination and facilitation of all activities of the Food and Drug Administration that may have any effect on a pediatric population or the practice of pediatrics or may in any other way involve pediatric issues, including increasing pediatric access to medical devices.
The staff of the Office of Pediatric Therapeutics shall coordinate with employees of the Department of Health and Human Services who exercise responsibilities relating to pediatric therapeutics and shall include—
At least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.
- Best Pharmaceuticals for Children ActHouse: no recorded tallySenate: no recorded tally
- Food and Drug Administration Amendments Act of 2007House: 405–7Senate: no recorded tally
- Food and Drug Administration Safety and Innovation ActHouse: no recorded tallySenate: 96–1
- FDA Reauthorization Act of 2017House: no recorded tallySenate: 94–1