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United States · Bill · S

S. 812 (107th)

Greater Access to Affordable Pharmaceuticals Act of 2002

openUnited States· United States Congress· EN

Introduced

1 May 2001

Last action

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Status

Held at the desk.

Sponsors

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Subjects

Discovery layer

Source updated

21 April 2025

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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

8 official files

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