FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF FOODS AND VETERINARY MEDICINE
CENTER FOR VETERINARY MEDICINE
OFFICE OF SURVEILLANCE AND COMPLIANCE
DIVISION OF VETERINARY PRODUCT SAFETY
Effective: October 1, 2012
1. DIVISION OF VETERINARY PRODUCT SAFETY (DJJVDD).
A. Monitors adverse drug event database to identify safety signals and effectiveness issues of concern.
B. Evaluates adverse event reports to ensure labeling contains a current accurate safety profile, identifies unsafe products, and unsafe product uses.
C. Maintains liaison with other agencies and organizations engaged in similar activities to identify product interactions and coordinate activities.
D. Provides surveillance for adverse events involving consumption of pet food. Performs scientific and epidemiologic assessment of data as part of the pet food early warning system to assist the Division of Compliance in recognizing potential safety issues and establishing the need for product recalls.
E. Coordinates with FDA District Offices to receive and evaluate product defect reports for the identification of product safety issues. Interacts with other FDA centers to ensure appropriate investigatory and risk mitigation measures are taken by the Agency. Analyzes data and relevant information to assess the need for product recall(s).
F. Provides pre-market and post-market surveillance of drug product medication errors to CVM review Divisions.
G. Participates in outreach programs to encourage veterinarians to participate in the pharmacovigilance program and to educate veterinarians, animal owners, and the public regarding the medical risk and benefits of veterinary products.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Office were approved by the Secretary for Health and Human Services, effective October 1, 2012.