The Journey of an Animal Drug through the Approval Process-FDA

Jul. 25, 2023


FINISH LINE:  An approved animal drug on the market

Many of us may not be familiar with the path to the finish line, so let’s break it down to see how an animal drug makes the journey from being an idea to a product on the market. 

Helpful Definitions


Drug Sponsor

Approved New Animal Drug

Major and Minor Species

Conditional Approval and Indexing

Common Misconceptions

A Brief Summary of the Drug Approval Process

The Longer Version 

The Beginning:  The Idea

The First Steps:  Open Communication

The Puzzle Pieces

Target Animal Safety


Human Food Safety

Chemistry, Manufacturing, and Controls

Environmental Impact

All Other Information


The Freedom of Information Summary

The End:  The Puzzle is Complete

Over-the-Counter versus Prescription versus Veterinary Feed Directive Animal Drugs

Generic Animal Drugs

CVM’s Stamp of Approval

Animal Drugs @ FDA

The role of intramammary tube in the treatment of dairy cow endometritis

intramammary syringe

Application steps of pet syringe

pet syringe

Application steps of pet syringe

30ml dial a dose syringe

Specification and material introduction of plastic vaccine bottle

100ml PP vaccine vial

Specification and material introduction of plastic vaccine bottle

250ml PE plastic vaccine bottle

Precautions for using pet ear drops bottle

ear drop bottle

Source from FDA

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