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FDA Expedited Programs Guidance: “Available Therapies” Depends On U.S. Standard Of Care

 
• By Sue Sutter

Draft guidance explains the four expedited drug development and approval pathways and offers the agency’s first formal advice on the type and amount of evidence needed for designation as a “breakthrough therapy” under FDASIA.

To ensure that “breakthrough therapies” provide a real advance over existing therapy, FDA is clarifying that to qualify for the designation established under FDASIA, a candidate generally should be compared to a current standard of care that is FDA-approved for the same indication.

The agency’s first official instructions on the breakthrough therapy designation created under the FDA Safety and Innovation Act come as...

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US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 
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