Expanded Access: Practical, Legal, and Regulatory Considerations

Attendees discussed the advantages and drawbacks of the two pathways by which patients may now request access to investigational therapies. Among other things, we considered the impact of each avenue on long-term drug development, the resources necessary for handling requests in a timely and consistent manner, and the optimal contents of organizational policies, considering the perspectives of both pharmaceutical companies and large academic healthcare facilities.

Deliverables