Topic: Uncategorized

Expedited Development for All: the Phase 2c Pathway

FDA’s Expedited Programs for Serious Conditions, as well as the Orphan Drug Designation, remain exceptional by design. However, the time has come to consider ways of transforming the exception into the rule: providing the benefits of expedited programs beyond products for serious conditions with unmet medical needs. The success of FDA’s expedited programs demonstrates that… Read more »