Published in FDA Law Weekly, November 17th, 2005
DOR announced that the investigational new drug application (IND) for its orBec program had been transferred from the U.S. Food & Drug Administration's (FDA) gastrointestinal products division to the oncology drug products division. From its inception till the present time, the orBec IND has been held and guided by the gastrointestinal division.
DOR has been and will continue to be in contact with the oncology division in the coming weeks to review the orBec program and plan for the new drug application (NDA) filing. In its initial correspondence with DOR about the...
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