Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry and FDA Staff: Application User Fees for Combination Products. The document provides guidance on marketing application user fees for combination products and describes how the “barrier to innovation” waiver provision under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act may be applied to innovative combination products in the infrequent situation where FDA requires the submission of two marketing applications. To download this guidance, click here. To view this notice, click here.
