In the early stages of the pharmaceutical drug approval process, it is essential to maximize outcomes of the pre-Investigational New Drug (IND) meeting with FDA. Understanding how to navigate initial steps and communications with FDA is a critical first step.
This course will provide an outline for how to establish personnel roles working toward the effort, and will provide strategies to enhance study outcomes, meet goals, and work within specific timeframes. We will discuss general expectations for a Pre-IND meeting and requirements for the Pre-IND meeting packet. The course also will review other aspects of the Pre-IND phase, such as the Request for Designation (RFD), types of FDA accelerated approval programs, and the basics of documentation and laboratory notebook management.