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 publishing a proposed regulation to further define the term ``adequate and well-controlled'' to require that field investigations be designed and conducted in a scientifically sound manner. Elsewhere in this issue of the Federal Register, FDA is reopening docket number 96N-0411 to receive comments regarding a concept, ``good study practices,'' that is related to the definition of adequate and well-controlled studies.