GUIDANCE DOCUMENT
CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process December 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Submit Comments by
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2023-D-3740
- Docket Number:
- FDA-2023-D-3740
- Issued by:
-
Guidance Issuing OfficeCenter 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.
Questions?
- Dr. Michelle Hyre
- Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-133
Rockville, MD 20855
- michelle.hyre@fda.hhs.gov
- 240-402-0593