Navigating Regulatory and Patent Challenges in the Combination Products Space The combination products sector is an exciting intersection of drugs, devices, and biologics, offering immense potential to revolutionize healthcare. However, with this potential comes a [...]

Agenda and Expectations for the 2024 Combination Products Summit: Navigating the Future of Healthcare The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, [...]

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 [...]

You’ve heard the term, “cure-all”, I’m sure, but as we all know, there is no real “cure-all” in life. If you ever watched the movie, “My Big Fat Greek Wedding”, then you are all too familiar [...]

Few disciplines are as closely related as science and engineering yet a huge divide exists between the two. Close collaboration between scientists and engineers is required in the development of combination products. Bridging the divide between the [...]

Combination products offer novel or improved treatment options, but can present significant regulatory and risk management challenges. Because these products incorporate two or more regulated components, the ability to achieve regulatory compliance and managing compliance [...]