ClinicalPharmacologyTherapeutics

ClinicalPharmacologyTherapeutics - perspec tives...

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468 VOLUME 85 NUMBER 5 | MAY 2009 | www.nature.com/cpt PERSPECTIVES 1 Office of Combination Products, US Food and Drug Administration, Rockville, Maryland, USA. Correspondence: KJ Lauritsen ( [email protected] ) doi: 10.1038/clpt.2009.28 Combination Products Regulation at the FDA KJ Lauritsen 1 and T Nguyen 1 The US Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of drugs, biological products, and medical devices. As single-entity products, drugs are generally regulated by the Center for Drug Evaluation and Research (CDER), devices by the Center for Devices and Radiological Health (CDRH), and biologics by the Center for Biologics Evaluation and Research (CBER). In recent years, technological advances have led to a blurring of the historical lines of separation between the centers. Compared with single-entity devices such as drugs and biologics, combina- tion products have the potential to pro- vide enhanced therapeutic advantages. More and more combination products are incorporating cutting-edge tech- nologies that hold great promise for advancing patient care. Combination products range in complexity from drug-eluting stents to gene therapy systems and from chemotherapeutic drugs combined with monoclonal anti- bodies to novel nanotechnology-based drug delivery systems. They include innovative products for diagnostic and therapeutic treatments of cardiovascu- lar, metabolic, and oncologic disorders, among others. Some estimates forecast that the combination-products mar- ket could increase from approximately US$6 billion in 2004 to nearly $10 bil- lion by 2009. 1 Furthermore, some esti- mate that the total global value of the drug–device combination-products market will increase from $5.4 billion in 2004 to $11.5 billion in 2010. 2 Coinci- dent with these estimates, the Food and Drug Administration (FDA) has seen a steady rise in the number of marketing applications for combination products ( Figure 1 ). Combination products also raise challenging regulatory, policy, sci- entific, and review management issues. The FDA’s Office of Combination Prod- ucts (OCP) addresses these issues by classifying combination products, determining where they are reviewed, and developing regulations, policy, and guidance for industry and review staff. What is a combination product? As their name implies, combination products combine two or more differ- ent single-entity products—a drug com- bined with a device, a drug combined with a biologic, a device combined with a biologic, or a device combined with both a drug and a biologic. They may also be combined in multiple ways: physically, chemically, or otherwise; packaged together (co-packaged); or provided separately but specifically labeled for use together. These products are defined in Title 21 of the Code of Federal Regulations (CFR) 3.2(e).
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