No Excuses: US FDA Wants Early, Thorough Dosage Optimization For Cancer Drugs

 
• By Sue Sutter

Breakthrough therapy designation is not a sufficient reason to avoid identifying an optimal dosage prior to submitting a marketing application, agency says in draft guidance under Project Optimus. Guidelines also emphasize randomized comparisons of multiple dosages and exploration of tolerability issues.

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US FDA wants sponsors to focus more attention on dosage optimization before submitting a marketing application. • Source: Shutterstock

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