Guidance for Industry on Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements.'' As required by the Food and Drug Administration Modernization Act of 1997 (Modernization Act), this guidance for industry describes the standards for the prompt review of efficacy supplements. It also is intended to define those efficacy supplements that are eligible for priority review.