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 guidance.
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:
- Clinical Research Support, including Monitoring and Compliance, Training and Education, and the Institution-Sponsored IND (ISI) Program;
- Institutional Review Office/Institutional Review Board;
- Office of the General Counsel; and
- Ethics and Compliance Office
- Provide guidance and assistance for preparation and review of regulatory submissions such as initial INDs and IDEs, Expanded Access (single-patient, treatment, compassionate use) INDs, safety reports, annual reports, and other FDA correspondence.
- Provide support for communications between Fred Hutch and the FDA, and/or act as the FDA liaison for sponsor-investigator held INDs or IDEs.
- Assist with preparation and serve as FDA liaison for FDA inspections of Consortium investigator or sponsor-investigator activities.
- Provide investigators, sponsor-investigators, Clinical Research Support, and others with guidance on regulatory, GCP, and cGMP issues that may arise during conduct of a clinical trial.
- Interpret and stay current with federal, state and local regulations, policies and trends that affect the Consortium clinical research activities, and communicate new information to the relevant departments and individuals.
- Provide general regulatory advice as needed.
General inquires, contact: RegulatoryAffairs@fredhutch.org
Immediate Notification of FDA Inspection:
Senior Regulatory Affairs Associate