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                Compliance Program Manual

Compliance Program Manual Home
          Inspections, Compliance, Enforcement, and Criminal Investigations
          Compliance Manuals
          Compliance Program Manual
          Bioresearch Monitoring Program (BIMO) Compliance ProgramsCompliance Program Manual Bioresearch Monitoring Program (BIMO) Compliance Programs
  
  	
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			Compliance Program Title
			On-line Availability7348.003
			In Vivo Bioavailability-Bioequivalence Studies - Clinical
			
			PDF7348.004
			In Vivo Bioavailability-Bioequivalence Studies - Analytical
			
			PDF7348.007
			Inspection of Nonclinical Laboratories Conducting Animal Rule-Specific Studies
			
			PDF7348.808
			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
			
			PDF7348.811
			Clinical Investigators and Sponsor-Investigators
			
			PDF7353.001
			Postmarketing Adverse Drug Experience (PADE) Reporting Inspections
			
			PDF (335 kb)7353.001C
			Risk Evaluation and Mitigation Strategies (REMS) Reporting Inspections
			
			PDF

                                                                                  Content current as of:
      10/17/2022
              
              
Topic(s)
			  ComplianceCompliance Program Manual
 
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