1:15 pm – 3:00 pm Conditional approval (licensing with evaluation) – similarities and differences from post-approval study requirements.
1.15 pm Current practice in US for coverage with evidence development (CED) TBD- (FDA/CMS) representative;
1:40 pm Current practice in EU – IDEAL group- TBD
2:00 pm Think tank discussion:
- What is the potential scope of L&E?
- What are the barriers to wider adoption, US and international?
- What is your recommendation for use of L&E?
- Should RCTs or registries be incorporated into L&E, CED?