Draft guidance for use of published literature to support new animal drug approvals announced by FDA

The FDA has announced the availability of draft Guidance for Industry #106 entitled “The Use of Published Literature in Support of New Animal Drug Approvals.”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 offers guidance to animal drug sponsors on certain realms of the approval process in which the existing scientific literature may be helpful in supporting the approval of a new animal drug application, an abbreviated new animal drug application, or a conditionally approved new animal drug application.¹

According to the FDA,¹ the original guidance #106 published in 2000, “The Use of Published Literature in Support of New Animal Drug Approval,” specifically highlighted the use of a single article to support drug approval. Since then, animal drug sponsors have utilized literature to support various facets of animal drug development and approval (i.e., 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). Therefore, this draft guidance builds on the original guidance #106 by examining multiple uses of the scientific literature to support approval of a new animal drug.

Using published scientific literature maximizes current knowledge and may decrease the number of animals needed for research to support approval. Plus, in some circumstances, it may offer a solid foundation for reaching conclusions to support an approval.¹

Reference

FDA announces draft guidance for the use of published literature to support new animal drug approvals. News release. April 19, 2022. Accessed April 19, 2022. https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-draft-guidance-use-published-literature-support-new-animal-drug-approvals