Investigational New Animal Drug (INAD) Guidances
- 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 #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 #119 How CVM Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug
- 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 #197 Documenting Electronic Data Files and Statistical Analysis Programs
- CVM GFI #218 Cell-Based Products for Animal Use
- CVM GFI #226 Target Animal Safety Data Presentation and Statistical Analysis
- CVM GFI #237 Oncology Drugs for Companion Animals
- CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products
- 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 #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 #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 #290 (VICH GL61) – Pharmaceutical Development