Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products
Federal Register 2001 April 24; 66(79): 20589-20600
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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 Unknown author (United States. Food and Drug Administration [FDA], 2006-12)