Generics Guidances
- CVM GFI #35 Bioequivalence Guidance
- CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals
- 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 #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to VICH GL52) Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Draft Guidance GL52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 #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds
- 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 #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