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 collaborates with other Clinical Research Support areas to provide Consortium investigators and research staff with training, guidance, and tools that enable them to understand and comply with FDA requirements. Requirements may include Investigational New Drug (IND) and Investigational Device Exemptions (IDE) regulations, Good Clinical Practices (GCP) and related rules and guidance.
Regulatory Affairs provides guidance and assistance as needed to all Consortium member investigators conducting clinical research under FDA regulations. Support activities further include assisting sponsor-investigators in the preparation and review of regulatory submissions and correspondence with the FDA, related to both clinical research and Expanded Access INDs (also known as single-patient, treatment, or compassionate use INDs). The program also provides hands-on support, coaching, and institutional representation during FDA inspections of Consortium investigators.
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 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
Services
- 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.
Contact Us
General inquires, contact: RegulatoryAffairs@fredhutch.org
Immediate Notification of FDA Inspection:
Jennifer Davies
Senior Regulatory Affairs Associate
206-605-1305
jdavies@fredhutch.org
RegulatoryAffairs@fredhutch.org