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 SURVEILLANCE
Effective: October 1, 2012
l. DIVISION OF SURVEILLANCE (DJJVDA).
A. Evaluates the safety and effectiveness of marketed animal drugs, special dietary feeds, veterinary medical devices, and other veterinary medical products and recommends action to correct deficiencies resulting from inadequate directions for use, warnings, and cautionary information.
B. Evaluates drugs products labels and other information to determine new animal drug status, regulatory priority, acceptable conditions of use, and need for regulatory activity. Maintains and makes available inventory listings of all marketed animals drugs to ensure adequate information is available for regulatory activity and customer support. Coordinates with field to develop enforcement activity, obtains expert witnesses and performs other scientific and regulatory case development activities.
C. Reviews marketed product labeling to make recommendations concerning label revisions, regulatory supplements, suspension of manufacturing, and withdrawal of approval of new animal drugs to ensure marketed products are safe and effective.
D. Monitors and evaluates promotion of marketed veterinary drugs to ensure promoted claims are consistent with approved claims.
E. Manages compliance programs covering regulated industries in animal drugs, veterinary medical devices, and other veterinary medical products to ensure the effectiveness of the programs. Review establishment inspection reports, labeling, and other findings to determine whether regulated products are being marketed in accordance with the Act and Agency regulations and policy.
F. Evaluates the safety and effectiveness of marketed unapproved animal drugs, special dietary feeds, veterinary medical devices, and other veterinary medical products to establish medical risk as related to animal and public health. Coordinates with the Division of Compliance and other CVM Divisions to determine enforcement priorities and risk mitigation strategies.
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.