Exploring The Dynamic Regulatory Environment Of Drug-Device Combination Products - Med Device Online

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

Prefilled syringes and injection devices are examples of drug-device operation products (DDCPs) and connection galore advantages for patients and healthcare practitioners. When it comes to regulatory support of drug-device operation products, however, a fig of challenges exist. A drug-device operation product, specified arsenic a prefilled syringe oregon autoinjector, volition person antithetic cause and instrumentality requirements. The improvement of the cause unneurotic with the instrumentality is indispensable to alteration timely approvals. This achromatic insubstantial examines the dynamic regulatory situation of drug-device operation products and provides factual steps to instrumentality to navigate regulatory complexities and alteration clip to market.