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

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.

Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Tsourounis, M., Stuart, J., Smith, M., Toscani, M., Barone, J. Tags: Regulatory Science Source Type: research