What is the difference between a regulatory sponsor and a financial sponsor?
The regulatory sponsor holds the IND or IDE and is responsible to the FDA for compliance with all regulatory requirements. The financial sponsor (funding source) is providing funding and/or investigational product for the conduct of the study. In the case of an investigator-initiated study, the investigator is the regulatory sponsor. For a commercial (business and industry) IND/IDE, the company is both the regulatory and financial sponsor.
