NCCS joined with patient advocacy organizations in the Cancer Leadership Council (CLC) in submitting comments to the Reagan-Udall Foundation regarding the Draft Project Proposal for the Expanded Access Navigator for Individual Patient Access.
In our letter, we commend the revisions to guidance documents, FDA educational materials, and the FDA website related to expanded access and note that the revisions will benefit patients and physicians. However, one gap is information for patients and treating physicians about the process to request the consent of the drug sponsor for access to the investigational agent. We urge the Reagan-Udall Foundation to assume this informational role.
The letter goes on to offer additional advice about the Expanded Access Navigator proposal.
Read the full letter below.
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