Development of an oncology drug under one of the US Food and Drug Administration’s expedited regulatory programs is no excuse for failing to identify an optimal dosage prior to marketing approval, the agency says in a new draft guidance.
No Excuses: US FDA Wants Early, Thorough Dosage Optimization For Cancer Drugs
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a sufficient reason to avoid identifying an optimal dosage prior to submitting a marketing application, agency says in draft guidance under Project Optimus.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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