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- When seriously ill patients have exhausted all standard of care treatment options, the use of investigational agents may be warranted. However, not all patients qualify for clinical trials.
- In these instances, FDA's Expanded Access program (also known as "Compassionate Use"), may be allowed for use of investigational therapies outside of the traditional clinical trial space. However, this is a fairly complex and tightly regulated process whereby physicians and drug companies coordinate the allowable disposition of these treatments for particular patient uses through the Federal Drug Administration (FDA).
- The goal of the AIM team within Vanderbilt's Institute of Clinical and Translational Research (VICTR) is to facilitate communication among key stakeholders and provide support through all phases of the application process, from inquiry to FDA application to delivery of the investigational product.
- More detailed information on procedures for requesting Expanded Access use of an investigational medicine and additional information can be found on FDA's website.
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