Exploring The Dynamic Regulatory Environment Of Drug-Device Combination Products

By Diane Paskiet, Director of Scientific Affairs, West Pharmaceutical Services, Inc.

Prefilled syringes and injection devices are examples of drug-device combination products (DDCPs) and offer many advantages for patients and healthcare practitioners. When it comes to regulatory approval of drug-device combination products, however, a number of challenges exist. A drug-device combination product, such as a prefilled syringe or autoinjector, will have different drug and device requirements. The development of the drug together with the device is necessary to enable timely approvals. This white paper examines the dynamic regulatory environment of drug-device combination products and provides concrete steps to take to navigate regulatory complexities and decrease time to market.