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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
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
CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs   Food and Drug Administration (FDA) Proposed
CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices  Food and Drug Administration (FDA) Proposed
CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter   Food and Drug Administration (FDA) Proposed
CVM GFI #264 Standardized Medicated Feed Assay Limits  Food and Drug Administration (FDA) Proposed
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
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