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FDA Exploring Limited-Use Approvals For Antibiotics Based On Small Development Programs

 
• By Cathy Dombrowski

The agency would like to have a “special medical use” category for drugs, such as antibiotics for bacteria resistant to current therapies, that could be approved based on small trials and whose labeling says they should not be prescribed off-label.

FDA would like to have a new “special medical use” category for drugs that could be approved based on a small clinical development program and that would have a limited indication for specific populations.

The impetus for, and initial focus of, the program would be antibiotics for drug resistant bacteria, Commissioner Margaret Hamburg and...

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More from United States

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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.