Today, FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA (5223.6).” This MAPP describes the Office of Generic Drugs’ (OGD) and the Office of Surveillance and Epidemiology’s (OSE) policies and procedures for the assessment of the user interface of a drug-device combination product (generic combination product) submitted in an abbreviated new drug application (ANDA) or a pre-ANDA communication.
FDA’s draft guidance for industry, “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA,” provides a systematic approach for ANDA applicants to use in identifying and analyzing differences between the user interface of a proposed generic combination product and the user interface of its reference listed drug. Applicants should consult that guidance for recommendations on how to perform comparative analyses and what information to submit to FDA in their ANDAs.
Both OGD and OSE have differing expertise that may inform the review of comparative analyses of generic combination products. This MAPP clarifies OGD’s and OSE’s roles and responsibilities for the assessment of comparative analyses and comparative use human factors studies, and explains when OGD will consult OSE. Additionally, this MAPP outlines OGD’s and OSE’s policy for regularly scheduled meetings between OGD and OSE to support shared learning, awareness, and consistency—where applicable—in the assessment and characterization of user interface differences for combination products submitted under different application pathways (e.g., 505(j), 505(b)(2), and 351(k)).
For additional details, please refer to the full text of the MAPP.
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