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

Jul. 25, 2023

STARTING POINT:  An idea

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


Drugs

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

Effectiveness

Human Food Safety

Chemistry, Manufacturing, and Controls

Environmental Impact

All Other Information

Labeling

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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