Draft Guidance for Industry and Food and Drug Administration Staff: Application User Fees for Combination Products; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry and FDA Staff: Application User Fees for Combination Products." This draft guidance provides guidance to industry and FDA staff on marketing application user fees for combination products.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 (act) may be applied to innovative combination products in the infrequent situation where FDA requires the submission of two marketing applications.