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 FDA's Center for Veterinary Medicine (CVM) monitors adverse events for approved animal drugs, unapproved animal drugs, pet foods, and veterinary devices to identify safety signals and effectiveness issues of concern. For approved drug products, CVM scientists use the adverse drug event database to assist with decisions about product safety which may include changes to the label or other regulatory action. CVM also participates in outreach programs to encourage veterinarian participation in the pharmacovigilance program and to educate veterinarians, animal owners, and the public regarding the medical risks and benefits of veterinary products. Approximately 86,000 Adverse Drug Experience (ADE) reports are received annually. It is the largest animal drug adverse event database in the world, containing over 500,000 reports. Over the past two years, CVM significantly reduced a backlog of paper adverse event reports and made significant improvements to its electronic reporting systems. Over 95 percent of reports received in FY 2013 were submitted electronically, representing a twenty percent increase over the FY 2012 average. Year to date in FY 2014, CVM surpassed that goal receiving, on average, 97 percent of the reports electronically. This database provides CVM with the ability to data mine for safety signals and has applications for use in both pre- and post-market approval animal drug work. The efforts to increase the functionality and utilization of this pharmacovigilance database have improved animal drug safety. To learn more, visit the FDA-TRACK ADE Measures. |
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