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FDA announces draft guidance on using literature for drug approvals

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Document provides guidance to animal drug sponsors on specific areas of the approval process.

The U.S. Food and Drug Administration has announced the availability of draft Guidance for Industry #106 entitled “The Use of Published Literature in Support of New Animal Drug Approvals.”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  This draft guidance expands upon the original guidance #106 by considering multiple uses of the scientific literature to support approval of a new animal drug.

“Use of published scientific literature makes use of existing knowledge and may reduce the number of animals needed for studies to support approval, and in some cases, may provide a strong basis for drawing conclusions to support an approval,” the FDA noted.

Although the public may submit comments on any FDA guidance document at any time, the agency suggests comments on the draft guidance be submitted within 60 days to ensure that it considers the comment(s) before it begins work on the final version of the guidance document. 

To submit comments electronically, visit www.regulations.gov and type the following docket number into the search box: FDA-2021-D-1155.

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