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                Guidance for Industry

Guidance for Industry

                        Guidance by Number
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          Target Animal - Effectiveness - GuidancesGuidance for Industry Target Animal - Effectiveness - Guidances
  
  	
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    PrintCVM GFI #13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated Block
	CVM GFI #24 Drug Combinations for Use in Animals
	CVM GFI #37 Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for Pigmentation
	CVM GFI #38 Guideline for Effectiveness Evaluation of Topical/Otic Animal Drugs
	CVM GFI #49 Target Animal Safety And Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis Products (Lactating and Non-Lactating Cow Products)
	CVM GFI #50 Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products
	CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials
	CVM GFI #85 (VICH GL9) Good Clinical Practice
	CVM GFI #89 (VICH GL6) EIAs for Veterinary Medicinal Products - Phase I
	CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations
	CVM GFI #95 (VICH GL12) Effectiveness of Anthelmintics: Specific Recommendations for Bovines
	CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission
	CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals
	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 #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for Canines
	CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Felines
	CVM GFI #123 Development of Data Supporting Approval of NSAIDS for Use in Animal
	Computerized Systems Used in Clinical Investigations (PDF - 53KB)
	CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs
	CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for use in Companion Animals
	CVM GFI #215 Target Animal Safety & Effectiveness Protocol Development & Submission
	CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals
	CVM GFI #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle
	CVM GFI #261 Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs
	CVM GFI #264 Standardized Medicated Feed Assay Limits
	CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs
	CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs
	CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs
	CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs
	CVM GFI #276 Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs
	CVM GFI #281 Infectious Otitis Externa Drugs for Topical Use in Dogs
	CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals

                                                                                  Content current as of:
      11/08/2023Guidance for Industry

          
                        Guidance by Number
          Guidances Under Development for 2023
          Newly Added Guidances
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