Guidance for Industry and Food and Drug Administration Staff on Application User Fees for Combination Products; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled "Application User Fees for Combination Products." This document provides guidance to industry and FDA staff on marketing application user fees for combination products. The guidance also describes how the "barrier to innovation" waiver provision under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the act) may be applied to innovative combination products in the infrequent situation where FDA requires the submission of two marketing applications.