USFDA has now issued the draft regulations to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a proposed combination product including both a drug and a delivery device.

The recommendations included in the guidance deals with the analysis of the proposed user interface for the generic drug-device combination product. This includes the delivery device of the combination product and any associated controls and displays, as well as product labeling and packaging.

The regulatory noted that in the early stages of development, potential applicants should carefully consider the design of the user interface of a proposed generic combination product and seek to minimize differences from the user interface for the reference listed drug (RLD).

To facilitate that process, the guidance provides general principles, including how to conduct threshold analyses for the identification and the assessment of differences in the design of the proposed generic combination product when compared to its RLD.

Depending on the results of the threshold analyses, submission of additional data may be warranted, such as data from comparative use human factors studies, to assess the acceptability of differences identified in the user interface for the proposed generic drug.

The guidance states, “Drug products that are approved in ANDAs are generally considered by FDA to be therapeutically equivalent to their RLD. Products classified as therapeutically equivalent can be substituted with the full expectation that the generic product will produce the same clinical effect and safety profile as the RLD under the conditions specified in the labeling.

The regulator does not consider the comparative use human factors studies intended to demonstrate the safety or effectiveness of the proposed generic combination product. Rather, the comparative use human factors studies in this guidance are intended to confirm differences in device and labeling between the generic combination product and RLD.