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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
CVM GFI #241 Small Entity Compliance Guide – What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507)  Food and Drug Administration (FDA) Final
CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products  Food and Drug Administration (FDA) Final
CVM GFI #243 (VICH GL56) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods  Food and Drug Administration (FDA) Final
CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals  Food and Drug Administration (FDA) Final
CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution Reporting  Food and Drug Administration (FDA) Final
CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products  Food and Drug Administration (FDA) Final
CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products  Food and Drug Administration (FDA) Final
CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers  Food and Drug Administration (FDA) Final
CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances  Food and Drug Administration (FDA) Final
CVM GFI #257 (VICH GL57) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.