By notice dated January 30, 2008, the Therapeutic Products Directorate (TPD) and the Special Access Programme (SAP) published a final Guidance Document for the industry. The document is a revised version of the draft published for consultation in January 2007. As stated in the notice, the document provides guidance on access to unauthorized drugs through the SAP and clarifies the mandate, intent and scope of the program. Further, the process for requesting a drug through SAP is outlined.
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