Roche's Mazicon (flumazenil)
Is the equivalent of "approvable" after a Dec. 9 "NDA Day" held by the Pilot Drug Evaluation Staff, the company says. Roche filed an NDA for the injectable benzodiazepine antagonist for reversal of overdose in late 1990. . . . FDA blood/blood products QA workshop: Set for Jan. 21-22. FDA will examine tests used to establish quality and safety in the manufacture of blood and blood products, Dec. 13 Federal Register states. The workshop will be held at the Holiday Inn Bethesda, 8120 Wisconsin Ave. Register with Crosspaths Management Systems, Two Wisconsin Ave., Suite 600, Chevy Chase, Md. 20815. . . .
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