Greater Access to Affordable Pharmaceuticals Act of 2001

Summary

Greater Access to Affordable Pharmaceuticals Act of 2001 - Amends the Federal Food, Drug, and Cosmetic Act to provide for an accelerated date of approval for a generic drug application. Allows a drug to be considered a bioequivalent to a listed drug if the effects of such drug and the listed drug do not show a significant difference based on certain tests or studies. Sets forth requirements concerning the filing of a citizen petition review. Revises provisions concerning: (1) abbreviated new drug applications and new drug applications with respect to the time required for approval and the certification that a patent is invalid or will not be infringed; and (2) filing an application. Requires a report concerning the extent to which this Act has: (1) has enabled products to come to market in a fair and expeditious manner, consistent with the rights of patent owners under intellectual property law; and (2) has promoted lower prices of drugs and greater access to drugs through price competition..

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Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 16 May 2001

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• Introduced in House (PDF)

  Introduced in House · EN · 16 May 2001

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• Introduced in House

  summary · EN · 16 May 2001

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