MDUFMA Hiring Enables Dedicated Project Managers At Device Center
This article was originally published in The Gray Sheet
Executive Summary
CDRH estimates that by the end of fiscal 2003 it will have hired eight new project managers, which could bode well for future expedited PMA review times
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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 The April 8 document, issued in advance of a planned draft guidance on drug/test combinations, has a 90-day comment period (1"The Gray Sheet" April 18, 2005, p. 11).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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