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GUIDANCE DOCUMENT

CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials July 2001

Final
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The purpose of this document is to suggest a uniform system for writing study protocols and to provide a list of essential items that should be included in a study protocol.

Guidance #85 entitled "Good Clinical Practices" became final on May 15, 2001. Until the Center revises guidance #56, sponsors should follow the recommendations in guidance #85 when differences among the guidances occur.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.

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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