Scientific Publications by FDA Staff

Clin Transl Sci 2017 May;10(3):124-7

Case study for lean management in the public sector: improving combination product review at the Food & Drug Administration.

Rappel MJ, Hunter NL, Alexandrow AI, Hair KO, Sherman RE, Califf RM

Therapeutics known as combination products because they combine drug, device, and/or biologic elements can offer important advantages relative to single-modality products. However, regulatory policy in this arena has lagged relative to increases in product submissions and complexity of these products. In this article, we describe how the US Food and Drug Administration (FDA) applied Lean management methods to improve and streamline the process by which different FDA Centers and Offices coordinate review of combination products.