As part of the "FDA Initiative on Reinventing the Regulation of Cancer Drugs,'' the Cancer Liaison Program was charged with developing a process for recruitment, assessment, and selection of patient representatives to serve as members of cancer-related advisory committees in the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH). This initiative is intended to provide representation for cancer patients and to ensure that the selection process will provide for broad representation in the nominee pool, and to develop criteria for the selection of the patient representatives.
On December 13, 1996, the Lead Deputy Commissioner for Operations announced that patient representatives would have full voting privileges of FDA advisory committee members. Since that date, patient representatives have cast votes on therapies related to cancer.
The criteria for both the nomination and selection process will help ensure that the patient representative will provide the perspective of the patients with the disease for which a therapeutic product is being considered by the advisory committee.
Cancer Liaison Program
Office of Special Health Issues
Office of International and Consitituent Relations
October 6, 1999
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