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                Guidance for Industry

Guidance for Industry

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          Animal & Veterinary
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          Guidance for Industry
          Veterinary International Conference on Harmonization (VICH) Guidance DocumentsGuidance for Industry Veterinary International Conference on Harmonization (VICH) Guidance Documents
  
  	
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    PrintCVM GFI #63 - VICH GL1 - Validation of Analytical Procedures: Definition and Terminology
	CVM GFI #64 - VICH GL2 - Validation of Analytical Procedures: Methodology: Final Guidance
	CVM GFI #73 - VICH GL3(R) - Stability Testing of New Veterinary Drug Substances and Medicinal Products
	CVM GFI #74 - VICH GL4 - Stability Testing of New Veterinary Dosage Forms
	CVM GFI #75 - VICH GL5 - Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products
	CVM GFI #89 - VICH GL6 - EIA's for Veterinary Medicinal Products - Phase I
	CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations
	CVM GFI #91 - VICH GL8 - Stability Testing for Medicated Premixes
	CVM GFI #85 - VICH GL9 - Good Clinical Practices
	CVM GFI #92 - VICH GL10(R) - Impurities In New Veterinary Drug Substances
	CVM GFI #93 - VICH GL11(R) - Impurities in New Veterinary Medicinal Products
	CVM GFI #95 (VICH GL12) Effectiveness of Anthelmintics:  Specific Recommendations for Bovines
	CVM GFI #96 (VICH GL13) Effectiveness of Anthelmintics:  Specific Recommendations for Ovines
	CVM GFI #97 (VICH GL14) Effectiveness of Anthelmintics:  Specific Recommendations for Caprines
	CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines
	CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines
	CVM GFI #99 - VICH GL17 - Testing of New Biotechnological/Biological Products
	CVM GFI #100 - VICH GL18 (R2) - Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)
	CVM GFI #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for Canines
	CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Felines
	CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallus
	CVM GFI #115 - VICH GL22 -Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies
	CVM GFI #116 - VICH GL23 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing
	CVM GFI #117 - VICH GL24 - Management of Adverse Event Reports (AER's)
	CVM GFI #144 VICH GL27: Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial Resistance
	CVM GFI #141 - VICH GL28 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing,
	CVM GFI #142 - VICH GL29 - Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)
	CVM GFI #143 - VICH GL30 - Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms
	CVM GFI #147 - VICH GL31 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food Repeat-Dose (90 Day) Toxicity Testing
	CVM GFI #148 - VICH GL32 - Developmental Toxicity Testing
	CVM GFI #149 - VICH GL33 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing
	CVM GFI #214 - VICH GL35 - Electronic Standards for Transfer of Data
	CVM GFI #159 - VICH GL36 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI
	CVM GFI #160 - VICH GL37- Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing
	CVM GFI #166 - VICH GL38 - Environmental Impact Assessment's (EIA's) for Veterinary Medicinal Products (VMP's) - Phase II
	CVM GFI #176 - VICH GL39 - Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances
	CVM GFI #177 - VICH GL40 - Test Procedures/Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Product
	CVM GFI #185 - VICH GL43 -Target Animal Safety for Veterinary Pharmaceutical Products
	CVM GFI #198 - VICH GL45 - Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products
	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)
	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
	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
	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
	CVM GFI #219 - VICH GL51 - Statistical Evaluation of Stability Data
	CVM GFI #224 - VICH GL52 - Bioequivalence: Blood Level Bioequivalence Study
	Supplement to CVM GFI #224 - VICH GL52 - Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Draft Guidance GL52
	CVM GFI #225 - VICH GL53 - Electronic Exchange of Documents: File Format Recommendations
	CVM GFI #232 - VICH GL54 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)
	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
	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
	CVM GFI #259 - VICH GL58 - Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV
	CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products

                                                                                  Content current as of:
      01/24/2024Guidance for Industry

          
                        Guidance by Number
          Guidances Under Development for 2023
          Newly Added Guidances
          Withdrawn/Replaced Guidances
 
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