Conditional approval

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?

 

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