Historical FDA PDUFA Report

The Historical FDA PDUFA Report is a chronological table of PDUFA target dates as well as Advisory meetings (Adcom) that have already happened. PDUFA target dates are dates by which the FDA aims to deliver their approval decision regarding an NDA or BLA filing. These decisions can however come before the PDUFA target date. The table includes more insights including previous extensions, CRLs, and adcom votes.

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