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 #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 #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies 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 #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
Content current as of:
12/03/2024
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