Zdrowie i gospodarka · 25/05/2010
Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 188 entitled "Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine." The purpose of this draft guidance is to assist sponsors or non-applicants with filling out form FDA 1932, "Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report," as required by FDA regulations.