Adequate and Well-Controlled Studies for Investigational Use and Approval of New Animal Drugs

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The Food and Drug Administration (FDA), as directed by the Animal Drug Availability Act of 1996 (ADAA), is amending its regulations governing new animal drug applications to further define the term ``adequate and well-controlled studies.'' The purpose of this final rule is to further define ``adequate and well controlled'' to require that field investigations be designed and conducted in a scientifically sound manner, taking into account practical conditions in the field and differences between field conditions and laboratory conditions.