Regulatory Affairs provides expertise and support in the conduct of U.S. Food and Drug Administration (FDA)-regulated human subjects research within the Consortium. The program, working cooperatively with other Center programs, assists investigators performing clinical research under FDA regulations. Regulatory Affairs provides regulatory advice and services to all Consortium member investigators regarding their clinical research, as needed.
The program works with all of Clinical Research Support to ensure that Consortium investigators and their staff are familiar with FDA requirements for Investigational New Drug (IND) applications, Investigational Device Exemptions (IDE), Good Clinical Practices (GCP) and related rules and guidances.
The program provides support to clinical investigators in regulatory activities as well as assisting sponsor-investigators in the preparation and review of regulatory submissions and correspondence with the FDA. These activities include support for Expanded Access INDs (also known as single-patient, treatment, or compassionate use INDs).
In order to support and facilitate efforts in maintaining compliance with FDA, GCP, DHHS and other federal and state regulatory requirements, Regulatory Affairs works closely with many departments and services throughout Fred Hutch, including: