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  1. Prescription Drug User Fee Amendments

PDUFA VI: Assessment of Combination Product Review Practices in PDUFA VI

Combination products are therapeutic and diagnostic products that contain two or more types of medical products as constituent parts: a drug and device, a drug and biologic, a biologic and device, or all three (drug, biologic, and device). In 1991, the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH) entered into inter-center agreements to provide guidance on the classification and assignment of medical products and clarify jurisdiction over combination products. In 2002, the Office of Combination Products (OCP) was established to help achieve prompt assignment of combination products, promote the development of standardized guidance, support timely premarket reviews by the Centers, and support consistent and appropriate postmarket regulation.

As part of the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), FDA committed to contracting with an independent third party to assess current combination product review practices. The purpose of the assessment is to identify best practices and areas for improvement by FDA review staff and sponsors in the submission and review of combination products for consideration by both FDA and sponsors.


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