Inspections, Compliance, Enforcement, and Criminal Investigations

Bioresearch Monitoring Program (BIMO) Compliance Programs

Program #Compliance Program TitleOn-line Availability
7348.003In Vivo Bioavailability-Bioequivalence Studies - Clinical PDF 
7348.004In Vivo Bioavailability-Bioequivalence Studies - Analytical PDF 
7348.808Good Laboratory Practice (Nonclinical Laboratories) PDF(117 kb)
7348.808AGood Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit InspectionsHTMLPDF(38 kb)
7348.809Institutional Review Board PDF(293 kb)
7348.809ARadioactive Drug Research Committee PDF (155 kb)
7348.810Sponsors, Contract Research Organizations, and MonitorsHTMLPDF(80 kb)
7348.811Clinical InvestigatorsHTMLPDF(2437 kb)
7353.001Postmarketing Adverse Drug Experience (PADE) Reporting Inspections PDF (335 kb)
7353.001CRisk Evaluation and Mitigation Strategies (REMS) Reporting Inspections PDF

Page Last Updated: 10/01/2018
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