Guidance for Industry on Changes to Approved New Animal Drug Applications-New Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 191 entitled "Changes to Approved NADAs--New NADAs vs. Category II Supplemental NADAs." This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by FDA's Center for Veterinary Medicine (CVM).