2021 - The Veterinary Drug Approval Process and FDA Regulatory Oversight

Day 01(9:00 AM to 1:00 PM PDT)
Introduction to the Veterinary Drug Approval Process
Definitions
INAD/NADA technical sections
Some differences between human and animal drug approval process
FDA organization and jurisdiction
FDA Centers relevant to Animal Health
Introduction to Federal Regulations (FD&CA, AMDUCA, ADAA, FDAMA)
FDA Guidance documents and other online resources
Discovery/Acquisition - Preliminary Patent Protection Concerns
INAD/NADA Phased Review
Open an INAD File
Submit Early Information
Phased Review of Technical Sections
Meetings with CVM
Brief description of cGxP (GMP, GLP, GCP)
Day 02(9:00 AM to 1:00 PM PDT)
Developing the NADA Technical Sections
Chemistry, Manufacturing, Controls (CMC)
Effectiveness
The 7 Major Phases of Clinical Field Studies
Target Animal Safety (TAS)
Human Food Safety
Environmental Impact
Labeling
Freedom of Information (FOI) Summary
All Other Information (AOI)
Overview of Generic Animal Drugs (JINAD)
Submissions - ANADA sections
CMC
Bioequivalence (Safety & Efficacy)
Human Food Safety
Labeling
Day 03(9:00 AM to 1:00 PM PDT)
Minor Use Minor Species (MUMS)
Designation
Indexing
Marketing Exclusivity & Exclusive Marketing Rights
Animal Drug User Fees and related waivers
Animal Feed, OTC Drugs, Supplements, Medical Devices
Animal health products regulated by USDA & EPA
Non-Approval-Related Considerations
Extra-Label Drug Use
Compounding
Noncompliance and Enforcement
Pharmacovigilance
Post-approval submissions for CMC changes
Review of the Typical Steps in Veterinary Drug Development
Because procurement is handled differently in every company, we examine basic considerations only.