Combination drug products (i.e., products that are a combination of a medical device and/or a drug and/or a biologic) are inherently complex to manage, particularly due to regulatory approval processes. Three different FDA centers — the CDRH, the CBER, and the CDER — are involved in regulating these products, and although a lead center is assigned to a specific drug, the needed coordination and knowledge base required to manage the process is not easy.
In April 2016, the FDA announced its first Combination Products Policy Council. The Combination Products Policy Council will include senior-level team members who will focus on holding agency-wide discussions and making decisions on issues related to combination drug products. This council will “have decision-making authority on issues relating to combination products, cross-labeled products, and medical product classification.”
A lead center will still be designated based on the combination product’s determined primary mode of action (PMOA), but it appears the Combination Products Policy Council will take a more hands-on role in tapping required resources and expertise across the agency as the complexity of combination products increases. Read full article