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Streamlining Approval for Generic Animal Drugs

This act aims to simplify the approval process for generic animal drugs. This could lead to more affordable generic drug options becoming available, potentially lowering veterinary care costs for animal owners. These changes may impact the availability and pricing of medications for pets and livestock.
Key points
Simplifies bioequivalence study requirements for generic animal drugs, potentially speeding up their market entry.
Defines bioequivalence for animal drugs to require demonstration in at least one major species for which the drug is approved.
May lead to lower animal treatment costs due to increased competition and availability of cheaper alternatives.
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Additional Information
Print number: 117_HR_8857
Sponsor: Rep. Mace, Nancy [R-SC-1]
Process start date: 2022-09-15