What is it about?
This article offers 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.
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Why is it important?
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 article aims to address this gap in knowledge.
Perspectives
I hope that the work I undertook for this article that involved interviewing and surveying senior personnel in a highly competitive sector of the life sciences will help those at the cold-front who are trying to get their innovative medical technologies to those who need them the most, the patients.
Fiona Masterson
National University of Ireland
Read the Original
This page is a summary of: 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, Therapeutic Innovation & Regulatory Science, November 2017, SAGE Publications,
DOI: 10.1177/2168479017735142.
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