Durham, North Carolina
All PhUSE Single Day Events are FREE to members. To become a member click here. Registrations per company are limited to 20% of maximum attendance.
New Pathways to Approval
New pathways to approval – study/program designs that use methodologies other than traditional Phase I to III randomized trials. The FDA recently published a guidance about this, encouraging sponsors to use non-traditional approaches such as master protocols, basket protocols, continuous drug development and historical cohorts instead of placebo.
Jeff Abolafia, Rho
Ramesh Ayyappath, ICON
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