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GUIDANCE DOCUMENT

CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs July 2020

Draft

Not for implementation.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This guidance is being distributed for comment purposes only.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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2020-D-1396


Docket Number:
FDA-2020-D-1396
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance describes principles for designing, conducting, and reporting the results for investigations or studies, including data from foreign countries, in submissions to CVM to demonstrate substantial evidence of effectiveness for new animal drug applications or a reasonable expectation of effectiveness for applications for conditional approval of a new animal drug.  It also describes how sponsors may obtain feedback from CVM regarding the incorporation of data from foreign countries into investigations and study protocols before the submission of an application.  FDA is committed to supporting data that may be recognized globally in order to enhance animal drug development, facilitate the use of foreign data, and minimize the need to conduct duplicative studies. 

Questions?

Contact Point
Susan Storey
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-131
Rockville, MD 20855
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