The process of developing and approving new animal drugs is complex, lengthy, and costly. Only 1 in 20,000 proposed chemicals makes it through initial testing to be used on farms. From discovery to approval can take over 10 years of preliminary lab tests, animal trials to test dosage and safety, regulatory review, and monitoring after approval to ensure safety. The animal health industry has doubled spending over the past 10 years to over $400 million to navigate this rigorous process.

2. •Complex!
•Only 1 in 20,000 chemicals goes to the farm from the lab
• Only 1 in 200 makes it through pre-clinical testing and approval
• It can take 4 years to license an animal drug
• It can take 10+ years to take an animal drug from discovery to
approval
• In the past few years, the industry has spent over $400 million,
double what was spent 10 years ago

3. • Animal health products go through preliminary trials
• Tests conducted in test tubes
• Simple organisms are used like bacteria, mold, and yeast

4. • Tests are performed on animals to estimate dosage and check for
adverse effects
• If the trial is a success, the FDA is notified
• The FDA then approves further trials on drugs and food additives
• The USDA reviews plans for vaccines or other animal biologicals
• The EPA issues permits for some experiments

5. • Ensures the safety and effectiveness of the product
• Scientists work closely with manufacturers to make sure that all
necessary tests are being conducted
• Researchers conduct field trials to demonstrate how the product
works under normal conditions
• The manufacturer has to prove that it has produced a quality
product

6. • Tests are reviewed by the appropriate regulatory agency
• If the product is proven safe and effective, the government will
give the manufacturer permission to make and sell the product

7. • When the product is approved, its label becomes part of the
federal record
• The label cannot be changed without government approval

8. • As a final check, the government monitors the food supply for
illegal drug residues
• Random tests are conducted by the FDA, USDA, and FSIS
• The rate of violation has declined in the last 10 years
• Only 0.3% of samples have tested at illegal levels in the last few
years