US FDA Oncology Center Makes Dose Optimization Personal
‘Project Optimus’ is continuing to press forward on reframing the approach to dosing of anticancer drugs. The initiative is very personal to OCE Director Richard Pazdur.
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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a sufficient reason to avoid identifying an optimal dosage prior to submitting a marketing application, agency says in draft guidance under Project Optimus.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.
US FDA Neurology Drugs Program Gains Boost In FY 2023 Funding Bill Amid Calls To Clarify Development Policies
US FDA gains a nearly 7% increase in non-user fee funding, some of which will go for neurology drug guidance.
The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.