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Cancer Drug Dosage Optimization Starts With US FDA Meetings Early In Development

 
• By Sue Sutter

The agency’s final guidance retains a draft recommendation for a randomized, parallel dose-response trial when comparing multiple dosages, but is more forceful in wanting sponsors to talk to the FDA early if they want advice tailored to their development programs.

Nuts and bolts
The FDA recognizes there is no one size fits all approach to cancer drug dosage optimization. • Source: Shutterstock

A US Food and Drug Administration final guidance on cancer drug dosage optimization takes a more assertive tone about the need for sponsors to seek product-specific advice early in development, reassuring industry that it is not adopting a “one size fits all” approach.

The final guidance released on 8 August reiterates the draft document’s recommendation for a randomized, parallel dose-response trial when...

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More from Clinical Trials

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

EU Tests Unified Pathway For Combined Drug/IVD Studies

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

More from R&D

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.