Submitted to: Meeting Abstract
Publication Type: Abstract Only
Publication Acceptance Date: 7/20/2004
Publication Date: 8/3/2004
Citation: Straus, D.L. 2004. Status of research activities at SNARC [abstract]. Drug Approval Coordination Workshop Book of Abstracts. 10:21-22.
Technical Abstract: A brief overview of the Technical Sections completed and being worked on for the New Animal Drug Applications (NADAs) for copper sulfate and potassium permanganate will be discussed. Copper Sulfate NADA: Human Food Safety - Complete for all fin fish 02/09/2004 (submitted 05/16/1996). Environmental Assessment - asked EA team at FDA/CVM to provide info on needed data to fulfill this technical section more than a year ago and have not heard anything! Efficacy - Complete for Ich (12/15/1998). Target Animal Safety - Experimental phase completed 07/09/2001; Final Study Report submitted 07/01/2004. Potassium Permanganate NADA: Human Food Safety - Complete for all fin fish (07/26/1999). Environmental Assessment - Environmental Fate studies are being completed as initial phase of this Technical Section. Efficacy - Compound is not used to treat for Ich (as proposed) and preliminary studies indicate it has a low margin of safety; a phone survey indicated that there is a need to look at efficacy with external columnaris. Target Animal Safety - Experimental phase completed 08/25/1999; Final Study Report has not been worked on and may need to be re-run pending the outcome of the efficacy Technical Section