Post-Approval Reporting Guidances
Adverse Event Reporting
- CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's)
- CVM GFI #142 (VICH GL29) Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)
- CVM GFI #143 (VICH GL30) Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms
- CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
- CVM GFI #214 (VICH GL35) - Electronic Standards for Transfer of Data
Other Post-Approval Reporting
- Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act