Final Guidance for Industry: The Use of Published Literature in Support of New Animal Drug Approval; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (#106) entitled "The Use of Published Literature in Support of New Animal Drug Approval." The final guidance is intended to fulfill the section of the FDA Modernization Act of 1997 (FDAMA) that requires the agency to issue guidance to clarify the circumstances in which published matter may be the basis for approval of a supplemental application. The final guidance also clarifies the circumstances in which published literature may be the basis for approval of an original application. The final guidance is intended to provide specific advice on when FDA may be able to rely on published literature, with or without the submission of underlying data, to support new animal drug approvals.