Animal & Veterinary
OSC Ends 2010 with an Expansion
by Melanie McLean, DVM, Center for Veterinary Medicine, FDA
|An adverse event is an undesired side effect associated with a product, or a lack of effect (the product does not do what it is supposed to do).|
The responsibilities of the new division include:
- making sure the label for an approved animal drug has accurate safety information so veterinarians, animal producers, and pet owners are aware of any risks associated with the drug;
- working with FDA district offices on reports about defective animal products to identify safety issues;
- monitoring medication errors with animal drugs;
- participating in outreach programs to encourage veterinarians to report adverse events associated with animal products; and
- participating in outreach programs to inform the public about the medical risks and benefits of animal products.
Three teams make up the new division:
- Adverse Drug Event Review Team
- Adverse Event Review Team
- Data Management and Analysis Team
The work done by the three teams in OS&C’s new Division of Veterinary Product Safety supports CVM’s mission to protect human and animal health.