The FDA has established the Office of Combination Products , a new office created to streamline the processing of complex drug-device, drug-biologic, and device-biologic combination products - OCP - Government News in Brief - Brief Article

Drug Cost Management Report, Feb, 2003

* The FDA has established the Office of Combination Products (OCP), a new office created to streamline the processing of complex drug-device, drug-biologic, and device-biologic combination products. The OCP will be part of the Office of the Commissioner, and its responsibilities will cover the entire regulatory life cycle of combination products, including jurisdiction decisions, timeliness and effectiveness of pre-market review, and consistency and appropriateness of post-market regulation.

The primary regulatory responsibilities for specific combination products will remain in one of three product centers--the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, or the Center for Devices and Radiological Health--to which they are assigned. The new office will be headed by Mark Kramer, currently the Director of the Combination Products Program within the Office of the Ombudsman. Information: Media, 301-827-6242, or 888-INFO-FDA.