New Animal Drug Application Guidances
- CVM GFI #49 Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis
- CVM 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 #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process
- 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to VICH GL52) Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Draft Guidance GL52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 #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies
- 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 #285 - Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs
- CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products
- CVM GFI #287 - Raw Data for Safety and Effectiveness Studies
- CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use
- CVM GFI #290 (VICH GL61) – Pharmaceutical Development
- CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles