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Supplemental Policies: Use of Drugs in Outdoor Aquatic Research Facilities

Guide 1240.4270

Document format: pdf

Publisher: U.S. Food and Drug Administration

Creation date: October 1997

This document discusses the use of unaproved new animal drugs in aquatic species raised in research ponds or other outdoor containment facilities. It outlines FDA position on when such use would fall under regulation concerning laboratory research (which does not require prior FDA notification) and when it would be regulated under those relating to clinical studies (which requires prior FDA notification).

Key Words: USFDA • FDA • CVM • FDA Notification • Laboratory Research • Clinical Study • Pond