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.
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
250ml PE plastic vaccine bottle
Source from FDA
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