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..
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Sponsor introductory remarks on measure. (CR H2110)
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