Expanded Conditional Approval Draft Guidance Issued

Expanded Conditional Approval Draft Guidance Issued

September 27, 2019, Covington Alert

Yesterday, the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) issued a draft guidance explaining the criteria it plans to apply when granting “expanded conditional approval” to new animal drugs not intended for minor uses or minor species that address a serious or life-threatening disease or condition or fill an unmet animal or human health need, and that require for approval one or more complex or particularly difficult studies. Expanded conditional approval would allow such drugs to be marketed before fully approved while the sponsor completes the approval process.