Packaging Extra Effort: Packaging for Combination Products Producing a suitable package for a combination product requires device companies to understand the regulations, materials, and processes ...

The new Quality Management System Regulation (QMSR) that became effective on February 2, 2026, includes significant changes in the regulatory framework for combination drug-device and biologic-device ...

New opportunities to develop innovative — and often complex — products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should ...

As combination products have become more complex and sensitive, especially with more high concentration formulations and biologics, we recognized that there was a lack of systematic approach to ...

Developing a drug delivery device system (combination product) adds a layer of complexity to your pharmaceutical program that many companies underestimate until it's too late. Success depends not just ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination Products,” stressing as it did in the draft ...

Drug–device combination products are becoming increasingly prevalent, with many lasting years beyond the expiration date of primary and secondary patents on the drug itself. It is unknown how common ...

Veteran leader in drug-device development, regulatory strategy, and global standards partners with EdgeOne to strengthen expertise as combination product complexity grows EdgeOne Medical, an ...

- Abstract from trial evaluating Alpha DaRT ® in combination with pembrolizumab in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma selected for podium ...