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  1. Guidance & Regulatory Information

Selected Guidance Documents Applicable to Combination Products

Combination products are comprised of components that, individually, would usually be regulated by separate Centers under different types of regulatory authorities (i.e., biologics, devices, drugs). Each of the three review Centers involved in the assessment of combination products, the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH), maintains a comprehensive, regularly updated section of the FDA website that provides detailed information describing their specific organizational structures, how to contact each of the different Centers, and advice as to how applications should be prepared for submission to the respective Centers.

A limited number of guidance documents refer directly to combination products. As an aid to sponsors seeking to develop a combination product, the Office of Combination Products (OCP) is compiling an updated listing of guidance documents selected from those issued by CBER, CDER and CDRH that we believe would be of interest to combination product sponsors.  The list is not currently available.

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