GUIDANCE DOCUMENT
CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials July 2001
- Docket Number:
- FDA-2021-D-0611
- Issued by:
-
Guidance Issuing OfficeCenter 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
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-2021-D-0611.
Questions?
- CVM
- Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
- AskCVM@fda.hhs.gov
- (240) 402-7002