Factors that facilitate regulatory approval for drug/device combination products in the European Union and United States of America: a mixed method study of industry views
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Drug/device combination products play a vital role in diagnosis and treatment of a wide range of disorders, including chronic disorders such as heart disease, cancer, respiratory disease, and diabetes. Doctors consider them a vital part of healthcare. The market for these products is growing. They include and combine products that originate in the pharmaceutical, biopharmaceutical, biotechnology, and medical device sectors. Thus they draw on different conventions and face complex regulatory processes. No single regulatory framework has prevailed for these products and obtaining timely regulatory approval has proven challenging. However, research on these processes is scarce and the experience of life sciences companies bringing them to market remains poorly understood. This thesis enters this gap, offering insight into the experiences of those involved in obtaining regulatory approval of drug/device combination products in the European Union and the United States, and providing a conceptual model which life sciences companies can use when seeking regulatory approval for drug/device combination products.