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‘Project Facilitate’: US FDA Plans May Meeting On Expanded Access Call Center

 
• By Sue Sutter

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.

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A US FDA meeting in mid-May will gather feedback on agency plans for “Project Facilitate,” a pilot program aimed at making the single patient IND process easier to navigate for health care providers.

The Oncology Center of Excellence is developing a call center program through which regulatory project managers will help walk providers...

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