Combination products require more than pairing a drug with a delivery system. Their development demands coordinated planning across pharmaceutical, device, quality, regulatory, and clinical functions; often much earlier than organizations anticipate. While many companies recognize the importance of incorporating a device, it is still frequently introduced too late. This delay can create downstream challenges in design controls, human…
Combination products present a uniquely complex path from late-stage clinical development to commercial launch due to their need to comply with the corresponding drug, biologic, and medical device regulatory frameworks. The designation of Primary Mode of Action (PMOA) determines the lead regulatory authority and submission pathway, but it does not eliminate the obligation to address requirements from the non-lead constituent. As a…
Understanding a Streamlined Approach to Good Manufacturing Practice: Device-Sided vs. Drug-Sided Pathways in FDA’s CGMP Guidance Combination products such as drug-coated stents, prefilled syringes, and wearable injectors combine drug, device, and sometimes biologic components into a single product. While these products provide important therapeutic advantages, they also present unique regulatory challenges. To address these challenges,…
Risk management is central to ensuring the safety, quality, and efficacy of products in the healthcare sector. Two of the most prominent frameworks in this domain are ISO 14971 for medical devices and ICH Q9 for pharmaceuticals. While both aim to manage risks to patients, users, and the environment, they arise from different regulatory and…
In the highly regulated and rapidly evolving world of combination products, where drugs, devices, and/or biologics converge, the need for strategic portfolio management is more crucial than ever. One strategy gaining increasing traction is the platform approach. This model involves designing a foundational technology, system, or component that can be leveraged across multiple products within…
The regulatory landscape for medical devices, in-vitro diagnostics (IVDs), and other healthcare technologies is evolving rapidly in 2025. These changes aim to enhance safety, sustainability, and innovation while ensuring businesses comply effectively with new requirements. This blog will walk you through key developments, including updated EU regulations on medical devices, batteries, AI, packaging, and substance…
