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Animal Drug Fees Reauthorized: Faster Approvals and Stronger Fight Against Antibiotic Resistance.

This law reauthorizes the user fee programs for new and generic animal drugs until 2028, ensuring that pharmaceutical companies fund the FDA's review process to speed up drug approvals. This efficiency can lead to quicker access to necessary treatments for pets and livestock, and potentially lower costs for generic medications. Crucially, the act mandates enhanced reporting and activities focused on combating antimicrobial resistance in veterinary settings, which is vital for public health safety.
Key points
Extends industry funding for the FDA's animal drug review process through 2028, aiming for faster availability of new and generic animal medications.
Introduces new fees for companies seeking generic animal drug approval to streamline the regulatory workload.
Requires the FDA to report on and strengthen efforts to combat antimicrobial resistance in animals, protecting both animal and human health.
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Additional Information
Animal Drug and Animal Generic Drug User Fee Amendments of 2023
Print number: HR 1418
Sponsor: Rep. Pence, Greg [R-IN-6]
Process start date: 2023-03-07