Advantages And Disadvantages For The Sponsor

For the expanded-use study to be cost-effective for the sponsor, little or no funding should be expended for patient expense reimbursement or for investigators who desire to prescribe the investigational drug to their patients. However, it is the sponsor's responsibility to provide clinical trial material (investigational study drug) with appropriate labeling and instructions for use (including but not limited to the investigator brochure), appropriate recording instruments, and the medical, scientific, and monitoring expertise to conduct the trials in accordance with the expanded-use protocol and the current FDA regulations and guidelines.

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