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 301-827-6221
Fax 301-827-6748
(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)