Proposed Rules. Institutional Review Boards: Requiring Sponsors and Investigators to Inform IRBs of Any Prior IRB Reviews
Federal Register 2002 March 6; 67(44): 10115-10116 [Online] Available: http://frwebgate.access.gpo.gov/cgi-bin/multidb.cgi [6/4/03]
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Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception From Informed Consent Requirements for Emergency Research: Notice Unknown author (United States. Food and Drug Administration [FDA], 2006-08-29)