Guidance for Clinical Invetigators, Institutional Review Boards and Sponsors. Process for Handling Referrals to FDA Under 21 CFR 50.54. Additional Safeguards for Children in Clinical Investigations
Rockville, MD: Food and Drug Administration [FDA] 2006 December: 9 p. [Online]. Accessed: http://www.fda.gov/cber/gdlns/childclininv.pdf [2008 November 26]
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Guidance for Institutional Review Boards, Clinical Investigations, and Sponsors: Exception From Informed Consent Requirements for Emergency Research: Draft Guidance Unknown author (United States. Food and Drug Administration [FDA], 2006-07)