Through 00-12, the FDA rejected approximately 29% of first-time marketing applications of NMEs due to uncertainties related to dose selection and choice of endpoint.
For those that resubmitted, the median delay to approval was a further 435 days. In 2016, a statistical approach received approval from the FDA as a strategy to overcome these problems.
In our upcoming webinar, we will provide practical examples of how to use this approach for your dose-finding study through various endpoints..
Speaker: Brian Fox, Research Statistician, Statsols
Duration: 60 minutes
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