Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.
One device has already received approval via the FDA CMS parallel review process, and as the extended pilot program is expected to expire in December 2015 manufacturers are curious as to what will happen next. Future steps of this program could include a regulatory focus on device classes as opposed to single devices, and expanding the parallel review mindset to earlier parts of regulatory processes like pre-submission programs which would certainly impact trial design and management. Optimizing parallel review is essential if manufacturers wish to gain full value from this innovative upcoming program, and clarifying program attributes will enable stronger decision making for clinical teams.
Rochelle Fink, MD, JD
Vice President, Clinical and Regulatory Affairs
Exact Sciences Corporation