This article was originally published in The Gray Sheet
Firm forms team of expert consultants to help it respond to issues raised by FDA and the agency's Oncology Drugs Advisory Committee during a Jan. 13 meeting to review the oral cancer diagnostic ("The Gray Sheet" Jan. 18, p. 19). The panel voted unanimously against approval, saying Zila needs to conduct another trial. "Zila is moving rapidly to revise and expand the clinical data" in its new drug application, the firm says. The 1% tolonium oral rinse was developed as a diagnostic adjunct in patients with oral lesions suspected or known to be malignant
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