Draft Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Annual Reports for Approved Premarket Approval Applications." This draft guidance document outlines the information required by a certain FDA regulation in periodic reports (usually referred to as annual reports) and FDA's recommendations for the level of detail that manufacturers should provide. This draft guidance is not final nor is it in effect at this time.