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Source: FDA, 4/19/22
Today the U.S. Food and Drug
Administration is announcing the availability of draft Guidance for Industry
#106 entitled “The Use of Published Literature in Support of New Animal Drug Approvals.” The document provides guidance to animal drug sponsors on specific areas of the approval process where the available scientific literature may be useful to support the approval of a new animal drug application, an abbreviated new animal drug application, or a conditionally approved new animal drug application.The original guidance #106, “The Use of Published Literature in Support of New Animal Drug Approval,” was published in 2000 and specifically addressed the use of a single article to support drug approval. Since its publication, animal drug sponsors have used literature to support various aspects of animal drug development and approval, including early stages of drug development, dosage characterization, microbial food safety, design of the target animal safety evaluation, prediction of potential adverse effects, and substantial evidence of effectiveness. This draft guidance expands upon the original guidance #106 by considering multiple uses of the scientific literature to support approval of a new animal drug.
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