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Expanded Access: US FDA Application Data Suggest More Project Facilitate Outreach Needed

 
• By Derrick Gingery

Academic medical centers still submit the vast majority of applications to the FDA Oncology Center of Excellence’s expanded access program, suggesting many community hospitals and other providers may perceive barriers to the program.

cancer detection
OCE wants all oncologists to know they can use the expanded access program. • Source: Shutterstock

Oncology expanded access applications continue to emerge largely from academic institutions, which may prompt the US Food and Drug Administration’s Oncology Center of Excellence to continue boosting its outreach so providers in other settings may take advantage of the program.

Project Facilitate was created to help providers navigate the expanded access program. Agency officials will help providers complete the application and set up the necessary controls to use an unapproved...

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