Zdrowie i gospodarka · 20/06/2012

Draft Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 204 entitled "Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals." This draft guidance advises industry on the use of active controls in studies intended to provide substantial evidence of effectiveness of new animal drugs for use in companion animals. The intent of the guidance is to provide information to clinical investigators who conduct studies using active controls and have a basic understanding of statistical principles.