•Complex!•Only 1 in 20,000 chemicals goes to the farm from the lab• Only 1 in 200 makes it through pre-clinical testing an...
• Animal health products go through preliminary trials• Tests conducted in test tubes• Simple organisms are used like bact...
• Tests are performed on animals to estimate dosage and check foradverse effects• If the trial is a success, the FDA is no...
• Ensures the safety and effectiveness of the product• Scientists work closely with manufacturers to make sure that allnec...
• Tests are reviewed by the appropriate regulatory agency• If the product is proven safe and effective, the government wil...
• When the product is approved, its label becomes part of thefederal record• The label cannot be changed without governmen...
• As a final check, the government monitors the food supply forillegal drug residues• Random tests are conducted by the FD...
Seven Steps to Product Approval
Upcoming SlideShare
Loading in …5
×

Seven Steps to Product Approval

309 views
251 views

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
309
On SlideShare
0
From Embeds
0
Number of Embeds
2
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Seven Steps to Product Approval

  1. 1. •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 toapproval• In the past few years, the industry has spent over $400 million,double what was spent 10 years ago
  2. 2. • Animal health products go through preliminary trials• Tests conducted in test tubes• Simple organisms are used like bacteria, mold, and yeast
  3. 3. • Tests are performed on animals to estimate dosage and check foradverse 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
  4. 4. • Ensures the safety and effectiveness of the product• Scientists work closely with manufacturers to make sure that allnecessary tests are being conducted• Researchers conduct field trials to demonstrate how the productworks under normal conditions• The manufacturer has to prove that it has produced a qualityproduct
  5. 5. • Tests are reviewed by the appropriate regulatory agency• If the product is proven safe and effective, the government willgive the manufacturer permission to make and sell the product
  6. 6. • When the product is approved, its label becomes part of thefederal record• The label cannot be changed without government approval
  7. 7. • As a final check, the government monitors the food supply forillegal 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 fewyears

×