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                Guidance for Industry

Guidance for Industry

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          Guidance for Industry
          New Animal Drug Application GuidancesGuidance for Industry New Animal Drug Application Guidances
  
  	
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    PrintCVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species
	CVM GFI #82 Development of Supplemental Applications for Approved New Animal Drugs
	CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA
	CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals
	CVM GFI #132 Administrative Applications and the Phased Review Process
	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
	CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs
	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
	CVM GFI #224 (VICH GL52) Bioequivalence: Blood Level Bioequivalence Study
	CVM GFI #224 (Supplement to VICH GL52) Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Draft Guidance GL52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 #231 Distributor Labeling for New Animal Drugs
	CVM GFI #233 Veterinary Feed Directive Common Format Questions and Answers
	CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products
	CVM GFI #240 Proprietary Names for New Animal Drugs
	CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products
	Postapproval Changes to Drug Substances Guidance for Industry  (PDF - 393KB)
	CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products
	CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products
	CVM GFI #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds
	CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs
	CVM GFI #263 - Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter
	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 #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals
	CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications
	CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting
	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
	CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process
	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

          
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