Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements : Guidance for Industry

Issue Date: May 1, 1998
Issued by: Center for Biologics Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final

Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements : Guidance for Industry

Section 403(a) of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act) requires that FDA “publish in the Federal Register standards for the prompt review of supplemental applications submitted for approved articles . . . .” The legislative history indicates that this provision was directed at certain types of efficacy supplements (i.e., supplemental applications proposing to add a new use of an approved drug to the product labeling). Section 403(b)(3) of the Modernization Act requires that FDA provide guidance to 2 “define supplemental applications that are eligible for priority review.” This guidance fulfills both Modernization Act requirements.

Download the Guidance Document