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- S.2394
S.2394: A bill 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 April 29, 2002
- Latest Major Action Oct. 8, 2002
Bill Sponsor
Bill Cosponsors
9 (8 Democrats, 2 Republicans)
Bill Summary
Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drugs and biological products 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
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment. Without written report.
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 547.
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By Senator Kennedy from Committee on Health, Education, Labor, and Pensions filed written report. Report No. 107-300. Additional views filed.
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| April 29, 2002 |
Introduced in the Senate by Hillary Rodham Clinton (D-N.Y.) |