Newly Added Guidances

Guidance Documents will be retained in this section of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.

Title	Issue Date
CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology	August 28, 2024
CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology	August 28, 2024
CVM GFI #293 - FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients	August 9, 2024
CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)	August 9, 2024
CVM GFI #100 (VICH GL18 (R2)) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)	July 25, 2024
CVM GFI #276 Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs	June 26, 2024
CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process	June 26, 2024
CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles	June 24, 2024
CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use	June 24, 2024
CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications	June 21, 2024
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	June 21, 2024
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection	June 21, 2024