The Office of IND Development and Regulatory Affairs (OIDRA) helps City of Hope investigators interact with governmental regulatory agencies and remain in compliance with United States Food and Drug Administration (FDA) requirements.
Part of the Center for Applied Technology Development, the OIDRA represents an extremely important component for shepherding therapies and other biomedical technologies through complex regulatory processes. Having an in-house office to handle the bureaucracy and stringent regulations that accompany new drug development allows City of Hope investigators to focus on their core competency: research.
Suenell Broyer, director of the OIDRA, has extensive experience in regulatory affairs, including investigational new drug (IND) applications, clinical trial services, quality control, promotion and labeling.
The OIDRA provides investigators tools such as document templates and a database of all active IND applications, which generates reminders to investigators to fulfill necessary IND commitments. These measures facilitate submissions to the FDA and, in so doing, help streamline the translation of basic research into patient clinical trials. The OIDRA has been well received by the FDA, and represents a paradigm shift in how institutions oversee and manage clinical trials.