Overview of Select PDUFA VII Innovative Meeting Programs

Description: The drug development landscape is evolving, and traditional clinical trials often take years to complete. PDUFA VI and VII include innovative programs that can provide new paths forward in this challenging environment. The purpose of this session is to discuss several programs that can enhance and support drug development and review: The Complex Innovative Trial Design (CID) and Model-Informed Drug Development (MIDD) Paired Meeting Programs; the Rare Disease Endpoint Advancement Pilot (RDEA); and the Advancing Real-World Evidence Program (RWE). Sponsors with proposals that are accepted into these programs are offered opportunities to interact with the FDA on a specific aspect of drug development. In this session, four presenters, as program management leads from CDER and CBER for these innovative review programs, will provide an overview of these programs and discuss the underlying regulatory processes. They will also discuss the disclosure aspect of the CID, RDEA, and RWE programs. As a result of this session, Regulatory Affairs Professionals will be better able to guide their drug development team on the regulatory processes and requirements for application and participation in these innovative meeting programs.