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Clinical trials monitoring

This article was originally published in The Gray Sheet

Executive Summary

FDA public meeting slated for Nov. 27 at the Hyatt Regency in Bethesda, Maryland will solicit comments on the draft "Guidance for Clinical Trial Sponsors: On the Establishment and Operation of Clinical Trial Data Monitoring Committees." 1FDA's guidance, which details the roles, responsibilities and operating procedures of DMCs, is posted at 2http://www.fda.gov/cber/gdlns/clindatmon.htm...

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