Review of Supplemental Applications for Approved New Animal Drugs; Center Responsibility and Standards for Prompt Review; Availability of Draft Guidance

Streszczenie

As required by the Food and Drug Administration Modernization Act of 1997 (FDAMA), the Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) is making available information regarding the approval of supplemental applications for approved new animal drugs. CVM is publishing standards for the prompt review of supplemental applications and referencing an existing guidance that describes how supplemental applications may qualify for priority review. CVM is also designating an individual within the Center who is responsible for encouraging the prompt review of supplemental applications and for working with sponsors to facilitate the development and submission of data to support supplemental applications. Further, CVM is describing its efforts to collaborate with other organizations and persons to identify published and unpublished studies that may support supplemental applications and to encourage sponsors to submit supplemental applications based on such studies. In addition, CVM is announcing the availability of a draft guidance entitled "Guidance for Industry: Development of Supplemental Applications for Approved New Animal Drugs." This draft guidance explains how