But in 2018, Congress extended FDA CVM’s authority and created the Expanded Conditional Approval (XCA) pathway. This new review process allows companies developing veterinary drugs for major species (i.e. cats, dogs, horses, cattle, swine, turkey, or chickens) in major uses (specifically addressing a serious or life-threatening condition or an unmet animal or human health need) to directly market and sell their drugs before collecting all necessary effectiveness data. In particular, the company needs to (1) complete a safety study, (2) have some rigorous argument for why their drug has a reasonable expectation of effectiveness, and (3) prove that an efficacy trial would be complex or particularly difficult to run.

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