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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 #205 (VICH GL46) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues (MRK)  Food and Drug Administration (FDA) Final
CVM GFI #206 (VICH GL47) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals  Food and Drug Administration (FDA) Final
CVM GFI #207 (VICH GL48) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs In Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods  Food and Drug Administration (FDA) Final
CVM GFI #208 (VICH GL49) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies  Food and Drug Administration (FDA) Final
CVM GFI #209 The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals  Food and Drug Administration (FDA) Final
CVM GFI #211 Residual Solvents in Animal Drug Products Questions and Answers  Food and Drug Administration (FDA) Final
CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209  Food and Drug Administration (FDA) Final
CVM GFI #214 (VICH GL35) Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data  Food and Drug Administration (FDA) Final
CVM GFI #215 Target Animal Safety & Effectiveness Protocol Development & Submission  Food and Drug Administration (FDA) Final
CVM GFI #216 Chemistry, Manufacturing, and Controls (CMC) Information - Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.