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- H.R.4730
H.R.4730: To amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information applicable to pediatric patients.
About This Bill
- This bill was introduced in the 107th Congress
- This bill is primarily about law
- Introduced May 14, 2002
- Latest Major Action June 3, 2002
Bill Sponsor
Bill Cosponsors
33 (33 Democrats, 1 Independent Democrat)
Bill 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...
(Source: Library of Congress)
Bill Actions
| Date | Description |
|---|---|
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Referred to the House Committee on Energy and Commerce.
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Referred to the Subcommittee on Health.
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| May 14, 2002 |
Introduced in the House by Henry A. Waxman (D-Calif.) |