Streamlining The Path To Market For Generic Drug-Device Combinations

Developing generic drug-device combination products (g-DDCPs) is a complex and time-consuming process that often requires extensive clinical trials and regulatory submissions. However, a new six-phase approach offers a more efficient and cost-effective alternative. This approach focuses on identifying and characterizing design differences between g-DDCPs and their reference listed drugs (RLDs) to assess their potential impact on safety, effectiveness, and substitutability. By using a risk-based approach and bridging studies, manufacturers can streamline the development process and bring g-DDCPs to market more quickly. Learn how this new approach has the potential to improve access to affordable generic medications and enhance patient care.