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Minor Use Animal Drug Program: Western Region


<ul> <LI>Identify the animal drug needs for minor species and minor uses in major species. <LI>Generate and disseminate data for the safe, effective, and legal use of drugs used primarily in therapy or reproductive management of minor animal species.<LI> Facilitate FDA/CVM approvals of drugs for minor species and minor uses.

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Non-Technical Summary: Federal regulations require extensive experimental data on efficacy, safety, and residue levels before any drug can be used in a food animal species. Data must be obtained for each animal species for which drug use is intended. At present, most minor species of food animals do not have the benefit of safe and effective drugs, such as are available for cattle, swine, and poultry. This situation has the potential for adverse effects upon both the producers and consumers of animal products. The purpose is to conduct a national program to obtain minor and specialty animal drug clearances (tolerances, exemptions, and registrations) in cooperation with state, federal and industry personnel. <P> Approach: A system has been developed to review, evaluate, and recommend the feasibility of each animal drug clearance project submitted and to implement the collection of research data needed to establish a labelled registration for the use in question. When a project is accepted, field and laboratory data will be obtained and submitted to the Minor Use Animal Drug Program office for submission of a petition to FDA/CVM for registration.

Tell, Lisa
University of California - Davis
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