FDA issues Priority Zoonotic Animal Drug draft guidance

The FDA has announced draft guidance aimed at helping animal drug sponsors pursue Priority Zoonotic Animal Drug (PZAD) designation for new animal drugs. These PZADs have the potential to prevent or treat a zoonotic disease in animals that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in humans. The guidance includes vector-borne diseases and is intended to expedite the development and review of these therapies.¹

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 group of products. According to the FDA, the agency recognizes that the health of people, animals, and their shared environment are intertwined. One Health approaches that are implemented such as this draft guidance help support approval of impactful new products to address health needs that cross these sectors.

This guidance also 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 agenda applies to products such as novel food ingredients, animal biotechnology products and tissue-based products, intentional genomic alternations in animals, cell-culture animal food ingredients, and more.²

The FDA is accepting public comments on the new draft guidance for 60 days from the date of publication in the Federal Register. The public should submit either electronic or written comments on the draft guidance by February 16, 2024, to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance.¹

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.”

References

1. FDA seeks public input on guidance for Priority Zoonotic Animal Drug Designation. News release. FDA. December 15, 2023. Accessed December 15, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-seeks-public-input-guidance-priority-zoonotic-animal-drug-designation?utm_medium=email&utm_source=govdelivery
2. McCafferty C. FDA releases Animal and Veterinary Innovation Agenda. dvm360. September 18, 2023. Accessed December 15, 2023. https://www.dvm360.com/view/fda-releases-animal-and-veterinary-innovation-agenda