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 In this section:

                Clinical Trials and Human Subject Protection

Clinical Trials and Human Subject Protection

                        BIMO Inspection Metrics
          HSP/BIMO Initiative
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
          ICH Guidance Documents
          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


                        Clinical Investigations Compliance & Enforcement
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          Clinical Trials and Human Subject Protection
          IND/IDE ContactsClinical Trials and Human Subject Protection IND/IDE Contacts
  
  	
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    PrintQuestions about biologics (other than gcp questions)

800-835-4709 or 240-402-8010
	[After the greeting, consumers and healthcare professionals press 1, manufacturers press 2, or for Freedom of Information Act requests press 3.]
	OCOD@fda.hhs.gov (consumers)
	Industry.Biologics@fda.gov (manufacturers' assistance)
	Questions about whether a product is subject to IND regulations: call 800-835-4709 or 240-402-8010Questions about drug products (other than gcp questions)

301-796-3400
	Druginfo@fda.hhs.gov
	Questions about whether a product is subject to IND regulations: call 301-796-3400Questions about medical devices (other than gcp questions)

DICE Web Page
	Manufacturer's assistance: 800-638-2041
	Consumer assistance: 888-INFO-FDA
	Questions about whether a product is subject to IDE regulations: call 301-796-5640

                                                                                  Content current as of:
      06/11/2020Clinical Trials and Human Subject Protection

          
                        BIMO Inspection Metrics
          HSP/BIMO Initiative
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
          ICH Guidance Documents
          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


                        Clinical Investigations Compliance & Enforcement
          FDA's Role: ClinicalTrials.gov Information
          Good Clinical Practice Educational Materials
          Report Problems to FDA
          Reporting Complaints Related to FDA-Regulated Clinical Trials
          Good Clinical Practice Inquiries
 
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