Brief

The Generic Animal Drug and Patent Term Restoration Act is a federal law that amends the Federal Food, Drug, and Cosmetic Act to allow for abbreviated new animal drug applications. This means that if a drug has already been approved for use in humans, a new application can be submitted with less information, similar to human generic drugs. The law also extends patent terms for certain products by up to five years to compensate for delays caused by regulatory review.

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Congress.gov

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