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Guidance Issuing OfficeCenter for Veterinary Medicine
This guidance is intended to remain in effect until November 7, 2023. For further information, refer to 88 FR 15417, March 13, 2023.
The Center for Veterinary Medicine is aware that the COVID-19 pandemic may have an impact on studies conducted to support new animal drug development. Many of the challenges noted in FDA’s Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, issued in March 2020, may arise during the conduct of studies intended to support the approval of new animal drugs. Therefore, we believe the general principles outlined in that guidance document may be applied to studies conducted to support animal drug development. In this guidance (CVM GFI #270), we provide specific recommendations as to how these principles may be applied to studies conducted to support new animal drug development to ensure the safety of animals, their owners, and study personnel, maintain compliance with good laboratory practice regulations and good clinical practice, and maintain the scientific integrity of the data.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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-2020-D-1140.