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

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.