Challenges in the Development of Drug/Device and Biologic/Device Combination Products in the United States and European Union: A Summary From the 2013 DIA Meeting on Combination Products

Marilyn Tsourounis; Jeffrey Stuart; Mary Ann Smith; Michael Toscani; Joseph Barone

doi:10.1177/2168479014553033

Challenges in the Development of Drug/Device and Biologic/Device Combination Products in the United States and European Union: A Summary From the 2013 DIA Meeting on Combination Products

Marilyn Tsourounis, Jeffrey Stuart, Mary Ann Smith, Michael Toscani, Joseph Barone

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

Compared with single-entity treatments, multientity or combination products have the potential to provide enhanced therapeutic utility. Because they involve components that would normally be overseen by different branches of health authorities (eg, different FDA centers), they raise numerous scientific, regulatory, policy, and review management challenges. This article summarizes the current status of the evolving combination product development landscape and potential options to address key challenges facing combination product developers. Continued collaboration and transparency among regulators, combination product developers, and other stakeholders is essential to streamlining the global combination product development and review process to ensure the availability of high-quality new products that are being used in a way that is safe and effective.

Original language	English (US)
Pages (from-to)	239-248
Number of pages	10
Journal	Therapeutic Innovation and Regulatory Science
Volume	49
Issue number	2
DOIs	https://doi.org/10.1177/2168479014553033
State	Published - Mar 15 2015

All Science Journal Classification (ASJC) codes

Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Public Health, Environmental and Occupational Health
Pharmacology (medical)

Keywords

Drug Information Association
Office of Combination Products
device

Access to Document

10.1177/2168479014553033

Cite this

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Tsourounis, M, Stuart, J, Smith, MA, Toscani, M & Barone, J 2015, 'Challenges in the Development of Drug/Device and Biologic/Device Combination Products in the United States and European Union: A Summary From the 2013 DIA Meeting on Combination Products', Therapeutic Innovation and Regulatory Science, vol. 49, no. 2, pp. 239-248. https://doi.org/10.1177/2168479014553033

Challenges in the Development of Drug/Device and Biologic/Device Combination Products in the United States and European Union : A Summary From the 2013 DIA Meeting on Combination Products. / Tsourounis, Marilyn; Stuart, Jeffrey; Smith, Mary Ann et al.

In: Therapeutic Innovation and Regulatory Science, Vol. 49, No. 2, 15.03.2015, p. 239-248.

Research output: Contribution to journal › Article › peer-review

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AB - Compared with single-entity treatments, multientity or combination products have the potential to provide enhanced therapeutic utility. Because they involve components that would normally be overseen by different branches of health authorities (eg, different FDA centers), they raise numerous scientific, regulatory, policy, and review management challenges. This article summarizes the current status of the evolving combination product development landscape and potential options to address key challenges facing combination product developers. Continued collaboration and transparency among regulators, combination product developers, and other stakeholders is essential to streamlining the global combination product development and review process to ensure the availability of high-quality new products that are being used in a way that is safe and effective.

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Challenges in the Development of Drug/Device and Biologic/Device Combination Products in the United States and European Union: A Summary From the 2013 DIA Meeting on Combination Products

Abstract

All Science Journal Classification (ASJC) codes

Keywords

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