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GUIDANCE DOCUMENT

CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process June 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2023-D-3740
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law in March 2020, added section 512A Priority zoonotic animal drugs to the FD&C Act, which provides for the designation of a new animal drug as a PZAD.  This legislation is intended to expedite the development and review of certain 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 outlines the eligibility criteria a new animal drug should meet to obtain PZAD designation and describes the process sponsors may use to request such designation.  In addition, this guidance identifies enhancements to expedite the PZAD review process.
 

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All written comments should be identified with this document's docket number: FDA-2023-D-3740.

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