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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 #160 (VICH GL37) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing  Food and Drug Administration (FDA) Final
CVM GFI #166 (VICH GL38) Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP’s) - Phase II  Food and Drug Administration (FDA) Final
CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information  Food and Drug Administration (FDA) Final
CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions  Food and Drug Administration (FDA) Final
CVM GFI #171 - Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media  Food and Drug Administration (FDA) Final
CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)  Food and Drug Administration (FDA) Final
CVM GFI #173 Appendix for the Animal Drug Sponsor Fees Under ADUFA  Food and Drug Administration (FDA) Final
CVM GFI #176 (VICH GL39) Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances  Food and Drug Administration (FDA) Final
CVM GFI #177 (VICH GL40) Test Procedures/Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products  Food and Drug Administration (FDA) Final
CVM GFI #178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.