United States Government Publishing Office
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United States
National Archives and Records Administration
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Regulatory Information
2003_register
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2010-09-23
article
List of Additional Drugs for Which Pediatric Studies Are Needed
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
National Institutes of Health
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United States Government Agency or Subagency
The National Institutes of Health (NIH) is providing notice of a ``List of Additional Drugs for Which Pediatric Studies Are Needed.'' This listing extends the initial list published in the Federal Register on January 21, 2003 (Volume 68, Number 13, pages 2789-2790). The NIH has developed the list in consultation with the Food and Drug Administration (FDA) and pediatric experts, as mandated by section 409I of the Best Pharmaceuticals for Children Act (BPCA), Public Law 107- 109. This list prioritizes additional drugs most in need of study for use by children to ensure their safety and efficacy. It will be updated regularly until the Act expires on October 1, 2007.
68 FR 48402
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https://www.govinfo.gov/content/pkg/FR-2003-08-13/pdf/03-20558.pdf
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68 FR 48402
List of Additional Drugs for Which Pediatric Studies Are Needed; Federal Register Vol. 68, Issue
NOTICE
03-20558
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
4140-01-P
03-20558
Notice.
The National Institutes of Health (NIH) is providing notice of a ``List of Additional Drugs for Which Pediatric Studies Are Needed.'' This listing extends the initial list published in the Federal Register on January 21, 2003 (Volume 68, Number 13, pages 2789-2790). The NIH has developed the list in consultation with the Food and Drug Administration (FDA) and pediatric experts, as mandated by section 409I of the Best Pharmaceuticals for Children Act (BPCA), Public Law 107- 109. This list prioritizes additional drugs most in need of study for use by children to ensure their safety and efficacy. It will be updated regularly until the Act expires on October 1, 2007.
This list is effective upon publication.
Dr. Donald Mattison, National Institute of Child Health and Human Development, 6100 Executive Boulevard, Room 4B-100, Rockville, MD, 20892, e-mail BestPharmaceuticals@mail.nih.gov, telephone 301-496-5097 (not a toll- free number).
Reports and guidance documents; availability:
Drugs for which pediatric studies are needed; list,
BestPharmaceuticals@mail.nih.gov
Federal Register
Vol. 68, no. 156
Office of the Federal Register, National Archives and Records Administration
2003-08-13
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Table of Contents:
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