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  1. Compliance Program Manual

Bioresearch Monitoring Program (BIMO) Compliance Programs

Program # Compliance Program Title On-line Availability
7348.003 In Vivo Bioavailability-Bioequivalence Studies - Clinical   PDF 
7348.004 In Vivo Bioavailability-Bioequivalence Studies - Analytical   PDF 
7348.007 Inspection of Nonclinical Laboratories Conducting Animal Rule-Specific Studies   PDF
7348.808 Good Laboratory Practice (Nonclinical Laboratories)   PDF(117 kb)
7348.808A Good Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit Inspections HTML PDF(38 kb)
7348.809 Institutional Review Board   PDF(293 kb)
7348.809A Radioactive Drug Research Committee   PDF (155 kb)
7348.810 Sponsors and Contract Research Organizations   PDF
7348.811 Clinical Investigators and Sponsor-Investigators   PDF
7353.001 Postmarketing Adverse Drug Experience (PADE) Reporting Inspections   PDF (335 kb)
7353.001C Risk Evaluation and Mitigation Strategies (REMS) Reporting Inspections   PDF
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