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Unsure About ‘Breakthrough’-Worthiness? Talk To FDA First

 
• By Sue Sutter

An early, informal conversation between a sponsor and the review division about the supportive data could help reduce the number of ‘breakthrough therapy’ designation requests that are ultimately denied, FDA and sponsors said.

Sponsors interested in seeking “breakthrough therapy” status should first consult their FDA review division to assess whether existing data potentially support designation under the expedited regulatory pathway.

Early consultation with agency reviewers would help reduce the number of requests that are ultimately rejected, saving the agency and...

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More from United States

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

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US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
• By Sue Sutter

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• By Bridget Silverman

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More from North America

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.