White Paper
Safe, Effective, and Substitutable
Generic drug-device combination products (g-DDCPs) play a vital role in the healthcare market. A new, simplified design assessment process should reduce development time and costs associated with regulatory compliance while encouraging device innovation.
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What's Inside
Battelle completed a three-year period research project supported in part by a grant from the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) to develop an alternative design assessment method for generic drug-device combination products (g-DDCPs).
The proposed alternative assessment method has the potential to reduce the timelines and costs associated with generic product development and regulatory approval, lessening the burden of developing safe, effective, and substitutable generic products and enable more innovation in g-DDCP design.
The Making of a g-DDCP
Better understand the process of making g-DDCPs and why they are a vital part of the healthcare industry.
The ANDA Process
The Abbreviated New Drug Application (ANDA) process is traditionally faster as the RLD’s clinical and safety data are used to support the generic product’s therapeutic equivalence.
Alternative Assessment Method
This six-phase process provides a clear and structured roadmap for g-DDCP design assessment and regulatory compliance process.
Simplifying the Process
Learn how this process provides a clear and structured overview for assessing g-DDCP differences.