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        Clinical Trials and Human Subject Protection

Reporting Complaints Related to FDA-Regulated Clinical Trials Home
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          Clinical Trials and Human Subject Protection
          Reporting Complaints Related to FDA-Regulated Clinical TrialsClinical Trials and Human Subject Protection Reporting Complaints Related to FDA-Regulated Clinical Trials
  	
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    PrintComplaints related to FDA-regulated clinical trials should be reported to the office responsible for the product involved:

**Biologics studies (including gene therapy and vaccine studies):**
Call 240-402-8010
Fax 301-595-1245
Email: ocod@fda.hhs.gov*(Division of Communication and Consumer Affairs, CBER)*

**Clinical and preclinical studies involving products regulated by the Center for Food Safety and Applied Nutirition (CFSAN):**
Call 240-402-1757
FAX 301-436-2668
Email: yuguang.wang@fda.hhs.gov*(Bioresearch Monitoring Program, Office of Center Director, CFSAN)*

**Drug studies:**
Call 301-796-3150
Fax 301-847-8748
Email: CDER-OSI-GCPReferrals@fda.hhs.gov*(Office of Scientific Investigations, Office of Compliance, CDER)*

**Medical Device studies:**
Call 301-796-5490
Fax 301-847-8136
Email: BIMO-CDRH@fda.hhs.gov*(Division of Bioresearch Monitoring, Office of Compliance, CDRH)*

**New animal drug studies:**
Call 240-402-7001
Fax 240-276-9241
Email: CVMBIMORequests@fda.hhs.gov*(Premarket Compliance and Administrative Actions Team, CVM)*

**Tobacco studies:**
Call 240-402-7970
Email: CTP-BIMO@fda.hhs.gov*(Office of Compliance and Enforcement, CTP)*

                                                                                  Content current as of:
      07/31/2018Reporting Complaints Related to FDA-Regulated Clinical Trials
 
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