Adverse Event Reporting |
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An adverse event is any undesirable occurrence after the use of an immunobiological product, including illness or reaction, whether or not the event was caused by the product. For products intended to diagnose disease, adverse events refer to anything that hinders discovery of the correct diagnosis.
The mission of the USDA is to ensure that animal immunobiologics are in compliance with the Virus-Serum-Toxin Act. Reports are assessed for the possibility of a product deficiency. When necessary, testing is performed or additional information sought. The USDA is, however, unable to make diagnoses or recommendations specific to individual cases. Some of the manufacturers do provide such services. Receipt of a report by the USDA does not necessarily imply that the product caused an adverse event, or even that a particular event actually occurred.
Adverse events may be reported to the:
- Manufacturer - Many biologics manufacturers maintain veterinary services departments to handle such reports and may also offer diagnostic advice, treatment recommendations, and guidance on product use.
- Center for Veterinary Biologics - Once an adverse event has been reported to the manufacturer, The CVB may be contacted:
- On-line: Adverse Event Electronic Report Form.
- By fax or mail: Download the pdf form (17kb) and FAX to (515) 232-7120 or by mail to the CVB.
- By telephone: Adverse events may also be reported by calling the CVB at (800) 752-6255.
- Veterinary drugs, medicated feeds, and animals devices are regulated by the Food and Drug Administration, Center for Veterinary Medicine (FDA, CVM) under the Food, Drug and Cosmetic Act. The CVM recommends that you first contact the manufacturer to report an adverse event. To contact the CVM directly, call (888) FDA-VETS.
- Topical insecticides. Most of the products used topically for the control of ectoparasites and insects on animals are regulated by the Environmental Protection Agency (EPA) under the Federal Insecticide Fungicide and Rodenticide Act. The EPA may be reached at (800) 858-7378.
See Common Questions on adverse event reporting/pharmacovigilance.
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