Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #261 entitled "Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs." This draft guidance is intended for persons interested in pursuing conditional approval of new animal drugs for certain major uses in major species. Eligibility for conditional approval has been expanded beyond minor uses in major species and minor species to include certain major uses. The Center for Veterinary Medicine (CVM) refers to the process for conditionally approving new animal drugs that are not minor use and minor species (MUMS) drugs as "expanded conditional approval." The purpose of expanded conditional approval is 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 This draft guidance defines certain terms, clarifies the eligibility criteria for expanded conditional approval, and describes the criteria CVM intends to consider when determining expanded condition