Pediatric Research Equity Act of 2007

Pub. L. 110–85

Also known as: Medical Device User Fee Amendments of 2007, Best Pharmaceuticals for Children Act of 2007, Prescription Drug User Fee Amendments of 2007, Food and Drug Administration Amendments Act of 2007, Pediatric Medical Device Safety and Improvement Act of 2007

US Codex doesn’t hold the enacted text of this law — the public-law corpus runs from the 113th Congress (2013) onward. What it changed in the U.S. Code, reconstructed from the credit notes, is listed below.

83 sections of the Code credited to this law, found between Public Law 109-482 and Public Law 110-180.

• 21 U.S.C. § 321 — Definitions; generally
• 21 U.S.C. § 331 — Prohibited acts
• 21 U.S.C. § 333 — Penalties
• 21 U.S.C. § 334 — Seizure
• 21 U.S.C. § 350f — Reportable food registry
• 21 U.S.C. § 352 — Misbranded drugs and devices
• 21 U.S.C. § 353b — Prereview of television advertisements
• 21 U.S.C. § 355 — New drugs
• 21 U.S.C. § 355-1 — 355–1. Risk evaluation and mitigation strategies
• 21 U.S.C. § 355a — Pediatric studies of drugs
• 21 U.S.C. § 355c — Research into pediatric uses for drugs and biological products
• 21 U.S.C. § 355d — Internal committee for review of pediatric plans, assessments, deferrals, and waivers
• 21 U.S.C. § 355e — Pharmaceutical security
• 21 U.S.C. § 360 — Registration of producers of drugs or devices
• 21 U.S.C. § 360a — Clinical trial guidance for antibiotic drugs
• 21 U.S.C. § 360e — Premarket approval
• 21 U.S.C. § 360e-1 — 360e–1. Pediatric uses of devices
• 21 U.S.C. § 360i — Records and reports on devices
• 21 U.S.C. § 360j — General provisions respecting control of devices intended for human use
• 21 U.S.C. § 360l — Postmarket surveillance
• 21 U.S.C. § 360m — Accredited persons
• 21 U.S.C. § 360n — Priority review to encourage treatments for tropical diseases
• 21 U.S.C. § 360ee — Grants and contracts for development of drugs for rare diseases and conditions
• 21 U.S.C. § 360bbb-5 — 360bbb–5. Critical Path Public-Private Partnerships
• 21 U.S.C. § 360bbb-6 — 360bbb–6. Risk communication
• 21 U.S.C. § 374 — Inspection
• 21 U.S.C. § 379d-1 — 379d–1. Conflicts of interest
• 21 U.S.C. § 379d-2 — 379d–2. Policy on the review and clearance of scientific articles published by FDA employees
• 21 U.S.C. § 379g — Definitions
• 21 U.S.C. § 379h — Authority to assess and use drug fees
• 21 U.S.C. § 379h-1 — 379h–1. Fees relating to advisory review of prescription-drug television advertising
• 21 U.S.C. § 379h-2 — 379h–2. Reauthorization; reporting requirements
• 21 U.S.C. § 379i — Definitions
• 21 U.S.C. § 379j — Authority to assess and use device fees
• 21 U.S.C. § 379j-1 — 379j–1. Reauthorization; reporting requirements
• 21 U.S.C. § 379j-11 — 379j–11. Definitions
• 21 U.S.C. § 379l — Education
• 21 U.S.C. § 379dd — Establishment and functions of the Foundation
• 21 U.S.C. § 379dd-1 — 379dd–1. Location of Foundation
• 21 U.S.C. § 379dd-2 — 379dd–2. Activities of the Food and Drug Administration
• 21 U.S.C. § 381 — Imports and exports
• 21 U.S.C. § 393a — Office of Pediatric Therapeutics
• 21 U.S.C. § 399a — Office of the Chief Scientist
• 21 U.S.C. § 2101 — Findings
• 21 U.S.C. § 2102 — Ensuring the safety of pet food
• 21 U.S.C. § 2103 — Ensuring efficient and effective communications during a recall
• 21 U.S.C. § 2104 — State and Federal cooperation
• 21 U.S.C. § 2105 — Enhanced aquaculture and seafood inspection
• 21 U.S.C. § 2106 — Consultation regarding genetically engineered seafood products
• 21 U.S.C. § 2107 — Sense of Congress
• 21 U.S.C. § 2108 — Annual report to Congress
• 21 U.S.C. § 2109 — Publication of annual reports
• 21 U.S.C. § 2110 — Rule of construction
• 42 U.S.C. § 247d-3b — 247d–3b. Partnerships for State and regional hospital preparedness to improve surge capacity
• 42 U.S.C. § 247d-5a — 247d–5a. Identification of clinically susceptible concentrations of antimicrobials
• 42 U.S.C. § 262 — Regulation of biological products
• 42 U.S.C. § 282 — Director of National Institutes of Health
• 42 U.S.C. § 283 — Biennial reports of Director of NIH
• 42 U.S.C. § 283a-2 — 283a–2. Annual reporting regarding training of graduate students for doctoral degrees
• 42 U.S.C. § 283a-3 — 283a–3. Establishment of program regarding DES
• 42 U.S.C. § 284m — Program for pediatric studies of drugs
• 42 U.S.C. § 285g-10 — 285g–10. Investment in tomorrow's pediatric researchers
• 42 U.S.C. § 288-6 — 288–6. Pediatric research loan repayment program
• 42 U.S.C. § 290b — Establishment and duties of Foundation
• 21 U.S.C. § 353c — Prereview of television advertisements
• 21 U.S.C. § 355–1 — Risk evaluation and mitigation strategies
• 21 U.S.C. § 360e–1 — Pediatric uses of devices
• 21 U.S.C. § 360bbb–5 — Critical Path Public-Private Partnerships
• 21 U.S.C. § 360bbb–6 — Risk communication
• 21 U.S.C. § 379d–1 — Conflicts of interest
• 21 U.S.C. § 379d–2 — Policy on the review and clearance of scientific articles published by FDA employees
• 21 U.S.C. § 379h–1 — Fees relating to advisory review of prescription-drug television advertising
• 21 U.S.C. § 379h–2 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j–1 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j–11 — Definitions
• 21 U.S.C. § 379dd–1 — Location of Foundation
• 21 U.S.C. § 379dd–2 — Activities of the Food and Drug Administration
• 42 U.S.C. § 247d–3b — Partnerships for State and regional hospital preparedness to improve surge capacity
• 42 U.S.C. § 247d–5a — Repealed.
• 42 U.S.C. § 283a–2 — Annual reporting regarding training of graduate students for doctoral degrees
• 42 U.S.C. § 283a–3 — Establishment of program regarding DES
• 42 U.S.C. § 284m–1 — Pediatric Advisory Committee
• 42 U.S.C. § 285g–10 — Investment in tomorrow’s pediatric researchers