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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Posts New Animal Drug Safety Page on Website

FDA Veterinarian Newsletter 2006 Volume XXI, No II

The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) has posted a new Animal Drug Safety page on the CVM website to help interested individuals easily locate safety information about drug products regulated by CVM.

Although CVM has historically placed considerable information about approved animal drugs on its website, inquiries from the public, particularly pet owners, about drug approvals indicated that people could not readily find the drug information they needed on the CVM website.

At CVM’s new Animal Drug Safety page you will find these links:

  • “FDA Database of Approved Animal Drug Products,” where you can search for approval information, including indications and withdrawal times about animal drugs.
  • “Freedom of Information Summaries,” which summarize the safety and effectiveness information submitted by the drug sponsor to support the approval of an original or supplemental new animal drug application. The indications for use, dosage form, route of administration, and the recommended dosage, are explained.
  • “Current Labels and Client Information Sheets,” which are current drug package labels and product information inserts provided by drug manufacturers for a select list of animal drugs.
  • “Adverse Drug Experience Reporting,” including the “Cumulative Adverse Drug Experiences Summaries Report,” mentioned above.
  • “Product Safety Information,” which includes “Dear Doctor” Letters for Animal Drugs (letters issued to veterinary medicine professionals by drug manufacturers alerting the professionals to important safety information) and other safety notifications, such as company press releases about product recalls.
  • “Notice of Regulatory Activity Letters to Pharmaceutical Companies,” which are the regulatory activity letters issued by CVM’s Division of Surveillance, Office of Surveillance and Compliance.

The page also includes links to these other sources of safety notifications.

  • CVM, FDA, and U.S. Health and Human Services news releases.
  • FDA Product Recalls, Alerts, and Warnings.
  • FDA Guidance Documents.
  • Information on “Judicious Use of Antimicrobials,” which is an approach to maximize therapeutic efficacy of antimicrobial drugs and minimize selection of resistant -microorganisms.
  • Information on the “Withdrawal of New Animal Drug Applications Process,” which includes links to regulations and policies CVM follows when it proposes the withdrawal of approval of new animal drugs.

The Animal Drug Safety page also links to a new “Animal Drug Safety Frequently Asked Questions (FAQ)” page. This page gives answers to the questions CVM often receives from the public.

Some of the FAQs are:

  • How to report an adverse reaction.
  • What extralabel use means.
  • How to find information about a drug prescribed by a veterinarian.
  • What is a valid veterinarian-client-patient-relationship.
  • What drugs are approved for a particular disease, and what the difference is between an over-the-counter drug and a prescription drug.

We hope you will find CVM’s new Animal Drug Safety web page both user-friendly and informative. Any questions or comments about these pages may be directed to the CVM Web Manager, Deborah Brooks (Deborah.Brooks@FDA.HHS.gov).