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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 Center for Drug Evaluation and Research Director Janet Woodcock told...

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More from United States

Saving Part D: US Medicare Advisors Sound The Alarm

 
• By Michael McCaughan

The US Medicare Patient Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
• By Sue Sutter

The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

More from North America

User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

 
• By Derrick Gingery

The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.

Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.