A bill to amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information applicable to pediatric patients.

Summary

Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drug and biological product to assess such drug's or product's safety and effectiveness for relevant pediatric subpopulations, including dosage. Permits extrapolation from adult studies where the course of the disease and the effects of the drug are sufficiently similar in all populations. Permits deferral of such assessments if adult studies are completed earlier and the applicant submits a plan for or a description of planned or ongoing pediatric studies. Authorizes the Secretary of Health and Human Services to specify a date for submission of pediatric assessments if a drug's or product's use or need in the pediatric populations so dictates. States that drugs or products with delayed assessments will be deemed misbranded and subject to seizure and injunctive proceedings, though not penalties. Permits full waiver of such assessments if: (1) studies are highly impracticable or impossible and the evidence suggests that the drug or product would be ineffective or unsafe in all pediatric age groups; or (2) there is no meaningful therapeutic advantage or benefit in the pediatric population and little risk if used as labeled. Permits partial waivers at the request of an applicant for a specific pediatric subpopulation if any of the full waiver grounds apply to that subpopulation or reasonable attempts for a pediatric formulation for that subpopulation have failed. Requires labels of these drugs or products to reflect such waivers.

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Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 1 August 2002

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• Reported to Senate (PDF)

  Reported to Senate · EN · 1 August 2002

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• Reported to Senate with amendment(s)

  summary · EN · 1 August 2002

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• Introduced in Senate (text)

  Introduced in Senate · EN · 29 April 2002

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 29 April 2002

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 29 April 2002

  Open at official source

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