Federal Agencies that Regulate Gene Therapy

The Department of Health and Human Services (DHHS)

The Office of Human Research Protections (OHRP)

OHRP Links to Reference Documents

The Food and Drug Administration (FDA)

FDA Center for Biologics Evaluation and Research (CBER)

CBER Resources for Cellular and Gene Therapy

FDA Center for Drug Evaluation and Research (CDER)

FDA Center for Devices and Radiological Health (CDRH)

The National Institutes of Health (NIH)

NIH Office of Biotechnology Activities (OBA)

NIH Office of Human Subjects Research (OHSR)