Reporting Complaints Related to FDA-Regulated Clinical Trials

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
Email: ocod@fda.hhs.gov
(Division of Communication and Consumer Affairs, CBER)

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

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

Studies regulated by CFSAN:
Call 240-402-2585
FAX 301-436-2605
Email:  Caren.Kieswetter@fda.hhs.gov
(Caren Kieswetter, MD, FACOG, Office of Food Defense, Communication, and Emergency Response, CFSAN)

New animal drug studies:
Call 240-276-9200
Fax 240-276-9241
Email:  CVMBIMORequests@fda.hhs.gov
(Premarket Compliance and Administrative Actions Team, CVM)