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Reporting Complaints Related to FDA-Regulated Clinical Trials

Updated August 2006

Complaints related to FDA-regulated clinical trials should be reported to the office handling the type of study involved:

Biologics studies (including gene therapy and vaccine studies):

Call 301-827-2000
Fax 301-827-3843
(Division of Communication and Consumer Affairs, CBER)

Drug studies:

Call 301-796-3150
Fax 301-847-8748
(Division of Scientific Investigations, Office of Compliance, CDER)

Medical Device studies:

Call 240-276-0125
Fax 240-276-0128
(Division of Bioresearch Monitoring, Office of Compliance, CDRH)

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