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GUIDANCE DOCUMENT

CVM GFI #270 - Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency April 2020

Final
Docket Number:
FDA-2020-D-1140
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

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. 


Submit Comments

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:

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-2020-D-1140.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002
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