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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 98-0276.