Regulatory Strategy For Combination Devices: Working With The FDA For Program Success

As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Combination products can be either two or more active pharmaceutical molecules, combined to address different aspects of a health condition, or the combination of a medical device and a small or large molecule product.

Such products require more complex target profiling. Several components of the target product profile (TPP) can be heavily affected by a sponsor’s chosen regulatory strategy, depending on the nature of each constituent and the known and unknown interactions that could occur in the combination product. While the potential for these effects may seem more obvious in the case of two chemically interacting drug molecules, the same is true with various device-device combinations. The regulatory strategy for developing such products needs to be well-designed and should factor in both adaptability and the manufacturing process to minimize overall program risk. Having an adaptive regulatory strategy is the key to beneficial interactions with the Agency from the beginning.