Expanded Access: Reducing The Contract Delay
Executive SummaryWhile the US FDA works to cut time necessary to approve expanded access applications, sponsors are creating delays by mandating patients and institutions sign contracts to gain access.
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Oncology Center of Excellence pilot program is intended to make the single patient IND process easier to navigate and more efficient; regulatory project managers will help walk providers through the process and provide contact information for drug companies and institutional review boards.
Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.
Web tool to help patients find expanded access program should go live in early June, focusing initially on oncology. That timing should help deflect efforts to enact “Right to Try” legislation.