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GUIDANCE DOCUMENT

CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for use in Companion Animals December 2015

Download the Final Guidance Document
Final
Docket Number:
FDA-2012-D-0419
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance document advises industry on the use of active controls in studies intended to provide substantial evidence of effectiveness to support product approval for new animal drugs used in cats, dogs, and horses (i.e., companion animals). This guidance document is directed at clinical investigators who conduct studies using active controls and have a basic understanding of statistical principles. In this document, CVM compares studies that use active controls to studies that use either placebo concurrent controls or untreated concurrent controls. CVM uses these comparisons to illustrate the appropriate use of an active control.

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Submit Comments Online

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-2012-D-0419.

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