Regulatory Affairs provides expertise and support in the conduct of U.S. Food and Drug Administration-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 addition, Regulatory Affairs provides guidance in Good Manufacturing Practices (cGMP)-compliant manufacturing at the Center of products used under investigator-sponsored 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 the Center, including:
- Clinical Research Support, including Protocol Review Coordination, Data and Safety Monitoring, internal monitoring and auditing of trials, Quality Assurance, and Training and Education;
- Shared Resources Services including the Biologics Production and Cell Processing Facilities;
- Institutional Review Offices, including human subjects research and animal care (IRB, IACUC);
- Environmental Health and Safety (Biosafety and Radiation Safety Committees); and
- Office of the General Counsel (privacy and confidentiality issues).
- 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 the Center 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 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.
- Assist sponsor-investigators and production facilities with the development of Chemistry, Manufacturing, and Controls information for cell and gene therapy products.
- Interpret and stay current with federal, state and local regulations, policies and trends that affect the Center's clinical research activities, and communicate new information to the relevant departments and individuals.
- Provide general regulatory advice as needed.