The FDA provides oversight for clinical trials of investigational drugs, biologic products and medical devices.
Clinical trials involving investigational drugs, biologics and/or devices are governed by specific FDA regulations. Numerous parties involved in the clinical trials process, including study sponsors, principal investigators and institutional review boards, are subject to applicable FDA regulations.
The FDA provides guidance documents that describe the FDA's current thinking about issues related to FDA-regulated clinical trials. In addition, the FDA publishes information sheets that provide guidance and recommendations for IRBs, clinical investigators and sponsors to help them fulfill their responsibilities to protect human subjects who participate in FDA-regulated research.
The FDA requires that study sponsors and clinical investigators complete forms specific to the type of study that is being conducted.
The most recent FDA warning letters can be accessed on the FDA website.
Lisa Richman Ballance, M.A., CPW, CCP
Executive director for clinical research and compliance
F. Gerard Moeller, M.D.
Associate vice president for clinical research
Clinical research communications specialist