S. 2843 · 100th Congress · enacted
Generic Animal Drug and Patent Term Restoration Act
Became Public Law No: 100-670.
Latest official action 1988-11-16 · Enacted
The bill, briefly
Generic Animal Drug and Patent Term Restoration Act - Title I: New Animal Drug Applications - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to authorize abbreviated applications for the approval of a new animal drug. Requires such application to show that permitted uses, ingredients, dosages, labeling, and other factors are the same as or bioequivalent to a new animal drug already approved. Requires such application to contain a certification relating to patents covering the approved drug. Requires an applicant who makes such a certification to state in the application that a specified notice has been given to each owner of the patent (or owner-representative) and the holder (or holder-representative) of the approved application for the drug or drug use claimed by the patent. Requires the permission of the Secretary of Health and Human Services before an abbreviated application may be submitted for a new drug whose route of administration, dosage form, or strength differ from that of an approved new animal drug or whose use with other animal drugs in animal feed differs from that of an approved new animal drug. Requires the Secretary to publish and update a list of the official and proprietary name of each new animal drug which has been approved and continues to be approved for safety and effectiveness, including patent information as it comes in. Directs the Secretar…
Congressional Research Service · 1988-09-28
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Politicians behind the bill
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What happened after enactment?
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