Draft Guidance for Industry: The Use of Published Literature in Support of New Animal Drug Approval; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability for comment of a draft guidance for industry entitled "The Use of Published Literature in Support of New Animal Drug Approval." The draft guidance is intended to fulfill the section of the FDA Modernization Act of 1997 (FDAMA) that requires the agency to issue guidance to clarify the circumstances in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 The draft guidance also clarifies the circumstances in which published literature may be the basis for approval of an original application. The draft guidance is intended to provide specific advice on when FDA may be able to rely on published literature, with or without the submission of underlying data, to support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