Research and Resources

Points to Consider

During the federal regulatory review and approval process, AHI provides suggested guidance – or “points to consider” – for company sponsors who are preparing study protocols for new medicines under review with the FDA’s Center for Veterinary Medicine.

Communications with FDA’s Center for Veterinary Medicine ONADE HFV-110 Review Division
October 5, 2009

CVM Helpful Hints for Labeling Submissions
September 22, 2009

Foreign Pre-Approval Inspections (PAI)
Pre-Approval Inspection Template
May 1, 2008

Protocol Submissions for the Division of Therapeutic Drugs for Non-Food Animals
November 5, 2007

Data Submissions for the CVM ONADE Primary Review Divisions
September 24, 2007