Orphan Drug Program Improvement Act of 2001

Summary

Orphan Drug Program Improvement Act of 2001 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services, respecting application approval or licensing, to conform the designation of a drug for a rare disease or condition (orphan drug) to reflect such drug's approved labeling. Exempts clinically superior subsequent orphan drugs from the seven-year prohibition of approval respecting a previously approved or licensed drug.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 31 January 2001

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• Introduced in House (PDF)

  Introduced in House · EN · 31 January 2001

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• Introduced in House

  summary · EN · 31 January 2001

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