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Risk Analysis for Veterinary Biologics, continued |
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SIF Category III Veterinary Biologics (PDF 20KB)
| Subcategories | |
| III-A | live vectored organisms |
| III-B-1 | transgenic plant-based--therapeutic/prophylactic use |
| III-B-2 | transgenic plant-based--diagnostics |
Risk Assessment Outline For Use in Preparing Risk Analyses For Biotechnology-Derived Products (PDF 73KB)
When submitting a Risk Analysis to the CVB for prelicense evaluation of a Category I, II, or III biotechnology-derived product, the Risk Analysis should contain the most current version of the SIF and a Risk Assessment based on safety characteristics of the vaccine.
Summary Information Format for Environmental Releases (PDF 16KB)
Risk analyses for new live conventionally derived and biotechnology-derived veterinary biologics need to include environmental release assessments, which evaluate the safety characteristics of the vaccine microorganism within the context of the target environment. This SIF identifies the information that should be included in release assessments.
Summary Information Format for the Importation of Veterinary Biological Products into the United States (PDF 24KB)
The Veterinary Biologics risk analysis model for importing veterinary biologics centers on the risk of introducing foreign animal disease into the United States through the importation of a contaminated veterinary biological product. This requires a thorough evaluation of all potential sources of contamination during the development and manufacture of the product. This SIF identifies the information regarding the facilities, reagents, production procedures, and testing procedures that should be evaluated.
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