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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 comparing multiple dosages. However, it also adds some advice on...

Key Takeaways

  • The FDA’s final guidance on oncology drug dosage optimization continues to recommend randomized, parallel dose-response trials when comparing multiple dosages.

  • The agency wants sponsors...

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Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

More from R&D

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.