Federal Register Notice: FDA is making available a guidance for industry and FDA staff entitled Application User Fees for Combination Products to provide guidance 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 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.
