Zdrowie i gospodarka · 29.09.2011
Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and Submission; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry ( 215) entitled "Target Animal Safety and Effectiveness Protocol Development and Submission." The purpose of this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine, Office of New Animal Drug Evaluation. The recommendations included in this guidance are intended to reduce the time to protocol concurrence.