- Docket Number:
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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.
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:
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.