Source: dvm360

The FDA has released draft guidance to aid animal drug sponsors in obtaining Priority Zoonotic Animal Drug (PZAD) designation for new drugs intended to prevent or treat zoonotic diseases in animals that could impact human health. PZADs address vector-borne diseases and aim to expedite the development and review of therapies. The FDA plans to collaborate with sponsors receiving PZAD designation to enhance predictability in product development, streamline submission quality, and improve approval efficiency.

This initiative aligns with the One Health concept, recognizing the interconnectedness of human, animal, and environmental health. The guidance supports the FDA’s Animal and Veterinary Innovation Agenda, focusing on prioritized needs in areas such as novel food ingredients, animal biotechnology, and intentional genomic alterations. Public comments on the draft guidance are welcomed until February 16, 2024.

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