December 15, 2023
Today, the U.S. Food and Drug Administration is issuing draft guidance intended to help animal drug sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation for a new animal drug. PZADs are new animal drugs that have the potential to prevent or treat a zoonotic disease in animals, including a vector-borne disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in humans. This guidance is intended to expedite the development and review of these drugs.
The FDA will be able to engage with sponsors of drugs that receive PZAD designation to improve the predictability of product development and review. This process is intended to help improve submission quality and efficiency of the approval process for this critical group of products. The FDA recognizes that the health of people, animals, and their shared environment are intertwined and implements One Health approaches, like this draft guidance, which will help support approval of impactful new products to address health needs that cross these sectors.
This guidance aligns with the goals of the FDA’s Animal and Veterinary Innovation Agenda by supporting technologies and products that address high-priority needs. Released in September 2023, the Agenda aims to foster product development and implement smart, risk-based approaches to regulating modern animal and veterinary products.
The FDA is accepting public comments on the draft guidance for 60 days from the date of publication in the Federal Register. The public should submit either electronic or written comments on the draft guidance by February 16, 2024, to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance.
Comments can be submitted electronically via the Federal eRulemaking Portal, or in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All submissions received must include the Docket No. FDA-2023-D-3740 for “Priority Zoonotic Animal Drug Designation And Review Process.”
For more information:
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.