Issue Date: January 17, 2017
Issued by: Center for Drug Evaluation and Research
Topic(s): Generic Drugs
Status: Draft
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry
This guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a proposed combination product that includes both a drug constituent part and a delivery device constituent part. The recommendations included in this guidance generally focus on the analysis of the proposed user interface for the generic drug-device combination product (generic combination product) when compared to the user interface for the reference listed drug (RLD). For the purposes of this guidance, the term user interface refers to all components of the combination product with which a user interacts. This includes the delivery device constituent part of the combination product and any associated controls and displays, as well as product labeling and packaging.
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