Event

This session will describe respiratory product development of generic drugs within the US, focusing on paths forward to bring safe and effective generic respiratory products to the American public. A general overview will summarize the generic drug approval process, focusing on the weight of evidence approach to bioequivalence used. Discussion of recent posted regulatory guidance and product approvals will provide the audience a greater understanding of the generic approval process, and how the use of emerging technologies and outcomes of research projects contribute to scientific understanding for these complex orally inhaled and nasal drug products to inform regulatory actions will be explained.