Substantial Evidence of Effectiveness 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 proposing to amend its new animal drug regulations to further define the term ``substantial evidence.'' The purpose of this proposed regulation is to encourage the submission of new animal drug applications (NADA's) and supplemental NADA's for single ingredient and combination new animal drugs. The proposal also encourages dose range labeling.