Generic drug device combination products: Regulatory and scientific considerations.

Complex regulatory and scientific considerations exist for drug-device combination products submitted under an Abbreviated New Drug Application. The Agency has published several guidances to aid industry in the development of a generic drug-device combination product: providing recommendations on the types of studies necessary to establish bioequivalence, providing considerations on product quality and performance for certain types of device constituents, and most recently, providing tools to assess the proposed user interface when compared to the user interface of the Reference Listed Drug. In addition, the Office of Generic Drugs1 has established a regulatory science research program intended to support projects that examine scientific questions relating to the development of generic combination products and their associated regulatory review. Several research examples are described within this article, which demonstrate how equivalence can be evaluated when the function of the device could potentially impact drug delivery. Moreover, this article provides an overview of regulatory recommendations and ongoing scientific research efforts to further develop guidances and ultimately improve public access to generic combination products. Published by Elsevier B.V.