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On October 26, 2002, Congress enacted MDUFMA. By amending the Federal Food, Drug, and Cosmetic Act, MDUFMA provided FDA with new responsibilities, resources, and challenges. Among other things, MDUFMA required FDA, not later than 60 days after the date of enactment, to establish an office within the Office of the Commissioner “to ensure the prompt assignment of combination products to agency centers, the timely and effective premarket review of such products, and consistent and appropriate postmarket regulation of” combination products. As required by MDUFMA, FDA established OCP within the Office of the Commissioner on December 24, 2002. Information about OCP, including the authorizing text of the MDUFMA amendments, can be found at http://www.fda.gov/oc/combination.
MDUFMA also requires FDA to submit an annual report to Congress on the activities and impact of OCP. This document fulfills this requirement for FY 2006.
Table of Contents | Overview of Combination Products