Submitted to: Meeting Abstract
Publication Type: Abstract only
Publication Acceptance Date: 7/26/2005
Publication Date: 8/1/2005
Citation: Straus, D.L. 2005. Status of aquaflor initial label claim [abstract]. Drug Approval Coordination Workshop Meeting Abstract. 11:58. Interpretive Summary:
Technical Abstract: A breif overview of the technical sections completed and being worked on for the New Animal Drug Application (NADA) for Aquaflor® will be presented. Various aspects of these technical sections will be opened for discusion. The Human Food Safety technical section is being completed by other researchers. The Efficacy technical section is being completed by other researchers. The Target Animal Safety technical section for catfish, tilapia and trout are being completed by other researchers. A Target Animal Safety study for hybrid striped bass is being undertaken by SNARC. The protocol has been submitted and is currently being reviewed by FDA/CVM; we have recently made CVM-requested amendments to the protocol. A pilot study is planned to verify that the doses won’t harm the HSB and the actual study will follow. The Environmental Assessment technical section is being completed by other researchers.