FDA Creates Office of Combination Products
by Erik Swain, Managing Editor
FDA has created an Office of Combination Products to better evaluate drug-device, drug-biologic, and device-biologic combination products and their packaging.
The office will assign a combination product to one of three centers for primary regulatory responsibility and help ensure timeliness and effectiveness of premarket review, as well as consistency and appropriateness of postmarket regulation. It will also coordinate any reviews that need the input of more than one center and resolve any relevant disputes. The three centers are the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.
The office, which will be part of the Office of the Commissioner, will also be charged with reviewing and, if necessary, modifying or eliminating any agreements, guidance documents, or practices specific to the assignment of combination products. It will also work with the centers to develop guidances or regulations to clarify how the agency handles combination products.