States that the filing of a citizen petition review shall not cause the Secretary of Health and Human Services to delay review and approval of an abbreviated new drug application unless the petition demonstrates through substantial scientific proof that approval would pose a threat to public health and safety.
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.
Provides for an accelerated date of approval of a generic drug application.
Expresses the sense of Congress that measures should be taken to effectuate the purpose of the Drug Price Competition and Patent Term Restoration Act of 1984 to make generic drugs more available and accessible, thereby reducing health care costs.
Introduced in House
Introduced in House
Referred to the House Committee on Commerce.
Referred to the Subcommittee on Health and Environment.
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