Device submissions for combination products: a data-driven perspective

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The rapid increase in novel therapies and innovative drug delivery methods particularly in the context of combination product regulatory submissions, requires the management of a significant amount of data between sponsors and regulators. Challenges arise when there is a lack of robust data management, and these challenges suggest a need to develop data-driven approaches for successful submissions and reviews. This article explores how data-driven approaches impact device submissions for combination products, highlighting challenges and opportunities that can be leveraged in the evolving regulatory landscape.

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