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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.
- Source :
- Therapeutic Innovation & Regulatory Science; Jul2018, Vol. 52 Issue 4, p489-498, 10p
- Publication Year :
- 2018
-
Abstract
- Background: The regulatory environment is one of the key factors in successfully bringing an innovative medical product, like a drug-device combination product, to market. This paper 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. Methods: The research consisted of two phases, qualitative data collection (through semi-structured interviews) and analysis, followed by quantitative data collection (through an online survey) and analysis. Results: A conceptual model was developed that depicted the facilitating factors for obtaining regulatory approval of a drug-device combination product, relevant to the European Union and United States systems, respectively. Conclusions: This model provides, for the first time, a comprehensive understanding of these factors, providing a foundation that could be adapted to reflect specific drug-device combination products. This research demonstrated originality of approach in interviewing thought leaders in the life sciences sector as well as conducting a survey that spans two of the largest jurisdictions for drug-device combination products in the world. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 21684790
- Volume :
- 52
- Issue :
- 4
- Database :
- Supplemental Index
- Journal :
- Therapeutic Innovation & Regulatory Science
- Publication Type :
- Academic Journal
- Accession number :
- 130661988
- Full Text :
- https://doi.org/10.1177/2168479017735142