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US FDA Expanded Access Pilot Launching Soon With Staffing Questions Unanswered

 
• By Derrick Gingery

New call center is designed to help physicians navigate the expanded access pathway for oncology products, but FDA officials are unsure about how much interest it will generate.

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US FDA officials will help physicians apply for oncology-related single-patient INDs through the Project Facilitate program.

Project Facilitate, the US Food and Drug Administration's pilot to help patients navigate the expanded access system, is set to launch later this month amid questions about the public interest it may generate.

Agency experts will be available to answer phone calls during business hours from physicians and help them complete the necessary forms and obtain needed authorizations for oncology-related single-patient IND applications

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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
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