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 uniquely challenging regulatory environment. The complex landscape of global regulations [...]

The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, devices, and biologics that present distinct challenges for development and commercialization. The 2024 Combination [...]

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 [...]

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 [...]