Continuing Education Credits are not available for the archived offering.
This Archived Webinar is available for purchase through June 30, 2016
Broadcast time: 1 hour 8 minutes

The passage of the FDA Safety and Innovation Act (FDASIA) holds the promise of a new era of open dialog and communication with FDA.  Under PDUFA V, the former NDA/BLA application review process was replaced by “the Program” which now includes additional meetings and correspondence with FDA about the ongoing status and any major issues identified within a submitted application.  As part of the Critical Path Initiative (CPI), FDA also sought to increase communication more broadly with stakeholders (e.g., Sponsors, investigators from industry, academia, patient advocacy groups, and government) to have general (non application-specific) discussions about how to tackle challenges in drug development.  With these Critical Path Innovation Meetings (CPIM) described under the Guidance for Industry: Critical Path Innovation Meetings (April 2015), the goal is for FDA and stakeholders to work together to identify new strategies that will lead to further innovation, improved efficiency, and greater success in drug development. 

In this webinar, FDA and industry experts will discuss the current FDA initiatives that support open dialog and communication between FDA and stakeholders; summarize the key findings from an independent assessment of the Program obtained by Eastern Research Group, Inc. (ERC); and provide specific FDA and industry perspectives on the Program and CPIM successes and limitations.