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Requested Rockvillv M3 2@1352 144 8 And by Facsimile d- Transmission CBER - 02 - 0 I) Harry D Bear, M D , Ph.D Llrglnia Commonwealth University 1200 East Broad Street W Hosprtal Room 7-408 fiichmontl, Vlrglnia- 23298-001 1 Lkar Dr Bear Warniciq Letter SEP 2,7 2o(M During an Inspection that ended on Apnl 29, 2002, Candlce Cartes, an investigator with the Food and Drug Adminlstratlon (FDA), reviewed your activities as a clmml invesllgator testing an Investigational melanoma vaccine In study The InspectIon was conducted as part of the FDAs Bioresearch Monitoring Program that Includes Inspectrons designed to revtew the conduct of cllnical research tnvolvlng investigational drugs We have determlned that you vlolated regulations governing the proper conduct of cllr)icciI sti131es lnvolvlng lnvesttgatlonal new drugs

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