Navigating the Complex Landscape of Combination Product Regulations
Elisa Kim, Mike Wallenstein, John “Barr” Weiner and Khaudeja Bano spoke at the Combination Products Summit. Source: Michele G. Sullivan
Insights From Combination Products Summit
The journey of developing and commercializing combination drug/device products is filled with challenges, primarily due to the non-harmonized global regulatory frameworks. As discussed at the recent 2023 Combination Products Summit, manufacturers face significant hurdles because different countries have their own definitions and requirements for these products. This lack of uniformity complicates the application process, adding layers of complexity and burdening manufacturers. Read more »
