AMDM Meeting In Brief
This article was originally published in The Gray Sheet
Executive Summary
Genomics concept paper: FDA in vitro diagnostics office seeks comments from diagnostic manufacturers on recently-released drug and diagnostic co-development preliminary FDL-1concept paper . "Anybody who has even a passing interest in this subject should take a look at that concept paper," OIVD Director Steve Gutman, MD, urges at an April 21-22 Association of Medical Diagnostics Manufacturers meeting. The April 8 document, issued in advance of a planned draft guidance on drug/test combinations, has a 90-day comment period (1"The Gray Sheet" April 18, 2005, p. 11). OIVD participation in the concept paper was significant and the office is working closely with CDER "because we do have such a strong interest on making genomics a success story," Gutman said. He nevertheless observed a shortage of diagnostics makers at the April 11-13 pharmacogenomics regulatory workshop sponsored by the Drug Information Association...
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