Independent Third-Party Assessment of Investigational New Drug FDA-Sponsor Communication Practices in Prescription Drug User Fee Act VI; Public Meeting; Request for Comments

Summary

The Food and Drug Administration (FDA) is hosting a public meeting to discuss an independent assessment of its communication practices with pharmaceutical sponsors during the development of new prescription drugs. The meeting will include presentations and a panel discussion, followed by an open public comment period, in response to the Prescription Drug User Fee Act (PDUFA) VI.