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# Guide on Animal Drug Expanded Conditional Approval
- URL: https://www.fdaweb.com/guide-on-animal-drug-expanded-conditional-approval/
- Published: 2019-09-30T12:00:00.000Z
- Updated: 2026-09-15T01:53:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145118

*Federal Register* notice: FDA has made available a draft guidance for industry #261 entitled “Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.” FDA says that eligibility for conditional approval has been expanded beyond minor uses in major species and minor species to include certain major uses. Expanded conditional approval is intended to incentivize development of new animal drugs for serious or life-threatening conditions or unmet animal or human health needs under circumstances where a demonstration of effectiveness would require a complex or particularly difficult study or studies. This guidance defines certain terms, clarifies the eligibility criteria, and describes the criteria CVM intends to consider when determining expanded conditional approval eligibility. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-09-30/pdf/2019-21002.pdf?ref=fdaweb.com).