Value the US Pharmaceutical Industry Places on Early Dialogue in the Drug Development Process

Abstract

This article addresses the value of early dialogue between the sponsor and the Food and Drug Administration (FDA) in the drug development process. Topics to be reviewed include how “early dialogue” came to be considered a valuable activity, who should be involved, when it should be undertaken, and some ideas on how to make it successful. Underlying all of this is the author's belief that the level of cooperation and trust between the company and the FDA will ultimately decide the real value of dialogue at any stage.