The Role of Comparative Analyses for Evaluation of Generic Drug-Device Combinations in an Abbreviated New Drug Application
Witzmann KA.
Respiratory Drug Delivery 2018. Volume 1, 2018: 231-236.
Abstract:
Important considerations are presented for comparative analyses, which are intended to identify and assess differences in the user interface of a proposed generic orally inhaled and nasal drug product (OINDP) as compared to the user interface for its reference listed drug (RLD). These comparative analyses, and early communications with the Agency, provide for a more predictable regulatory review that ultimately contribute to increased access to efficacious, safe, and therapeutically equivalent complex generic products for the American public.
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