INNOVATIONS in pharmacy

Development of Drug-Device Combination Products and Generic Substitution in the United States

An Overview

YoonJung Lee

Food and Drug Administration

https://orcid.org/0000-0002-8542-8991

Ila Srivastava

Food and Drug Administration

https://orcid.org/0000-0001-6692-6680

Katharine B. Feibus

Elizabeth R. Bielski

Food and Drug Administration

https://orcid.org/0000-0003-0838-6705

Lolita Sterrett

Food and Drug Administration

https://orcid.org/0009-0005-4461-2978

Danielle Harris

Food and Drug Administration

Markham C. Luke

Food and Drug Administration

DOI: https://doi.org/10.24926/iip.v16i2.6461

Keywords: drug-device combination product, therapeutic equivalence, generic substitution, regulatory, generic, complex product

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Abstract

Generic drug products approved and marketed in the United States include a variety of drug classes and dosage forms along with drug-device combination products (DDCPs). Development of DDCPs can pose scientific, regulatory, and legal challenges, and the Food and Drug Administration (FDA) has prioritized efforts to work with industry to improve scientific methodologies and application quality in an effort to provide quicker access to high-quality generic DDCPs. Once these products become available in the market, the roles of pharmacists and other healthcare providers (HCPs) become crucial. When prescribing, HCPs should provide risk/benefit counseling and, to prevent medication errors, teach patients about the proper use of these products. This review provides a comprehensive overview of the regulatory and developmental processes of generic DDCPs to help pharmacists and other healthcare professionals engage more effectively with patients.