Pediatric Research Initiative Act of 1995

Summary

TABLE OF CONTENTS: Title I: Biomedical and Behavioral Research Title II: Preventive Health Research Title III: Development of Improved Pharmaceuticals and Other Therapeutic Agents Pediatric Research Initiative Act of 1995 - Title I: Biomedical and Behavioral Research - Amends the Public Health Service Act to mandate a comprehensive plan for the conduct and support by the national research institutes of pediatric research. Establishes the National Advisory Council on Pediatric Research. Authorizes appropriations. Requires: (1) guidelines for the inclusion of children as subjects in clinical research projects conducted or supported by the National Institutes of Health; and (2) increasing the percentage of child subjects. Title II: Preventive Health Research - Mandates: (1) a program of research (directly or through grants) regarding preventable diseases, disabilities, and injuries in children; (2) an advisory committee; and (3) a comprehensive plan for the research. Establishes the Pediatric Prevention Research Initiative Fund. Authorizes appropriations. Title III: Development of Improved Pharmaceuticals and Other Therapeutic Agents - Amends the Federal Food, Drug, and Cosmetic Act to delay for a specified time (after the approval would otherwise be granted) the approval of new drugs for which the application materials refer to a drug whose approval application materials include pediatric clinical investigations. Allows the Secretary of Health and Human Services to consider pharmacokinetic studies as clinical investigations. Provides for requests for pediatric studies.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 25 May 1995

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• Introduced in House (PDF)

  Introduced in House · EN · 25 May 1995

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• Introduced in House

  summary · EN · 25 May 1995

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