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 & Regulatory Science
Marilyn TsourounisJoseph Barone

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.

References

Apr 22, 2009·Clinical Pharmacology and Therapeutics·K J Lauritsen, T Nguyen

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Citations

Mar 1, 2015·Therapeutic Innovation & Regulatory Science·Stephen P Spielberg

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