FDA Issues Draft Guidance on Expanded Conditional Approval for Animal Drugs

On September 30, 2019, FDA announced the availability of a draft guidance for Industry, titled “Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.”  This guidance addresses a special pathway for approval of animal drugs that address serious or life-threatening diseases or conditions, or an unmet animal or human health need, and for which demonstrating effectiveness would require complex or particularly difficult study or studies.  This new pathway is the result of an amendment in 2018.