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 »
Business continuity planning (BCP) is essential for the success of any enterprise, but it’s particularly crucial for companies in the life sciences industries, where criticality and compliance with FDA regulations may be impacted by a host of factors ranging from cybercrime to natural disasters to disruptions in the supply chain. Read more »
For companies in the Life Sciences industry, today’s climate—a mixture of competition, regulation, increasing consumer awareness, and continually evolving knowledge and capabilities—presents manufacturers of pharmaceuticals, medical devices, biologics, and combination products with a choice: maintain the status quo in product design, manufacture, and testing, or join the forward motion of the industry as well as the FDA in embracing the holistic and dynamic approach of Quality by Design (QbD). Read more »
