U.S. Food and Drug Administration
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Office of Pediatric Therapeutics

The Best Pharmaceuticals for Children Act [PDF]

The Best Pharmaceuticals for Children Act, P.L. 107-109 BPCA was signed into law January 4, 2002. BPCA renews and amends Section 111 of the Food and Drug Modernization Act. Provisions related to OPT:

  • Establishment of an Office of Pediatric Therapeutics and Ethicist Position.
  • Coordination and facilitation of all activities effecting the pediatric population or practice of pediatrics or involving pediatric issues.
  • Requires monitoring of Adverse Events for drugs granted pediatric exclusivity.

The Pediatric Research Equity Act [PDF]

The Pediatric Research Equity Act, P.L 108-155 was signed into law December 3, 2003. Provisions related to OPT:

  • Requires that all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, and new routes of administration must contain a pediatric assessment unless the sponsor has obtained a waiver or deferral of pediatric studies.
  • Established Pediatric Advisory Committee.

Ethics

Guidance Documents


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