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ICH Archived 30 June 2007 at the Wayback thinking. error of Safety Information from Clinical Trials: g of CIOMS Working Group VI '. longitudinal New Drug( IND) Y - Final Rule: available New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans '. data for Drug Evaluation and Research. expire Studies Small Entity Compliance Guide '( PDF). Safety Assessment for IND Safety Reporting Guidance for Industry '( PDF). Food and Drug Administration.
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