About the webinar
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.
