FDA Announces Draft Guidance for the Use of Published Literature to Support New Animal Drug Approvals
Update, March 15, 2023: The FDA has published final Guidance for Industry #106, “The Use of Published Literature in Support of New Animal Drug Approvals.” Minor editorial changes were made from the draft to final version of the document to improve clarity.
April 19, 2022
Today the U.S. Food and Drug Administration is announcing the availability of draft Guidance for Industry #106 entitled “The Use of Published Literature in Support of New Animal Drug Approvals.”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 This draft guidance expands upon the original guidance #106 by considering multiple uses of the scientific literature to support approval of a new animal drug.
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.
Although the public may submit comments on any FDA guidance document at any time, we suggest you submit comment(s) on the draft guidance within 60 days to ensure that the FDA considers your comment(s) before it begins work on the final version of the guidance document.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.
The public may also submit comments by mail using the address below:
Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
All submissions received must include the Docket No. FDA-2021-D-1155 for “The Use of Published Literature in Support of New Animal Drug Approvals.”
For more information:
- Draft Guidance for Industry #106, “The Use of Published Literature in Support of New Animal Drug Approvals”
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.