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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
CVM GFI #171 - Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products or Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media  Food and Drug Administration (FDA) Proposed
CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals  Food and Drug Administration (FDA) Proposed
CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs  Food and Drug Administration (FDA) Proposed
CVM GFI #219 (VICH GL51) Statistical Evaluation of Stability Data  Food and Drug Administration (FDA) Proposed
CVM GFI #239 Human Food By-Products For Use As Animal Food  Food and Drug Administration (FDA) Proposed
CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products  Food and Drug Administration (FDA) Proposed
CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals  Food and Drug Administration (FDA) Proposed
CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program  Food and Drug Administration (FDA) Proposed
CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers  Food and Drug Administration (FDA) Proposed
CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances  Food and Drug Administration (FDA) Proposed
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