In Brief: Tri-Med PYtest
This article was originally published in The Gray Sheet
Executive Summary
Tri-Med PYtest: Carbon-14 urea breath test for diagnosis of Helicobacter pylori is awaiting final FDA approval following March 7 submission of package insert clarifications requested by the agency in its Feb. 27 approvable letter to the firm. During February 1996 review of a new drug application for the test, FDA's Gastrointestinal Drugs Advisory Committee indicated that a confirmatory study of the diagnostic was inadequate because it did not generate appropriate control information ("The Gray Sheet" March 4, 1996, p. 17). Tri-Med says it submitted data on additional patients last fall to correct the deficiency...