Guidance for IRBs, Clinical Investigators, and Sponsors. IRB Continuing Review After Clinical Investigation Approval
Rockville, MD: Food and Drug Administration, 2010 January: 16 p. [Online]. Accessed: http://www.regulations.gov [2010 February 15]
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Adverse Event Reporting -- Improving Human Subject Protection. Guidance for Clinical Investigators, Sponsors and IRBs Unknown creator (United States. Food and Drug Administration [FDA]. Office of the Commissioner (OC) Center for Drug Evaluation and Research [CDER] (United States); Center for Biologics Evaluation and Research [CBER] (United States); Center for Devices and Radiological Hea, 2007-04)
Waiver of IRB Requirements for Drug and Biological Product Studies. Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Unknown creator (United States. Food and Drug Administration [FDA], 2006-01)
Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception From Informed Consent Requirements for Emergency Research: Notice Unknown creator (United States. Food and Drug Administration [FDA], 2006-08-29)